Center Valley, PA, United States
Olympus Corporation of the Americas recalls
134 recalls recorded since 2018, most recently on 27 August 2026. 108 are listed as ongoing. Status and classification are as published by the FDA.
Recalls134
Ongoing (FDA)108
Terminated or completed26
Class I (FDA)9
Ongoing Class II Medical devices
- Recall started
- 27 August 2026
- Reason
- While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
- Distribution
- Worldwide distribution - US Nationwide and the country of Poland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3329-2026
- Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System
Ongoing Class II Medical devices
- Recall started
- 24 August 2026
- Reason
- There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
- Distribution
- International distribution to the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3299-2026, Z-3300-2026
- Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
- Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Ongoing Class II Medical devices
- Recall started
- 19 August 2026
- Reason
- Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3247-2026, Z-3244-2026, Z-3246-2026, Z-3245-2026
- Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
- Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
- Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
- Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
Ongoing Class II Medical devices
- Recall started
- 19 August 2026
- Reason
- Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
- Distribution
- International distribution in the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3216-2026
- Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Ongoing Class II Medical devices
- Recall started
- 18 August 2026
- Reason
- Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
- Distribution
- Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3035-2026
- POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Ongoing Class II Medical devices
- Recall started
- 7 July 2026
- Reason
- Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2761-2026
- Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
Ongoing Class II Medical devices
- Recall started
- 16 June 2026
- Reason
- Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2776-2026
- Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Ongoing Class II Medical devices
- Recall started
- 5 June 2026
- Reason
- Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2676-2026
- Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and aro
Ongoing Class II Medical devices
- Recall started
- 5 May 2026
- Reason
- Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2720-2026, Z-2718-2026, Z-2721-2026, Z-2719-2026
- Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
- Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
- Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
- Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Ongoing Class II Medical devices
- Recall started
- 25 March 2026
- Reason
- XXX
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1903-2026, Z-1901-2026, Z-1907-2026, Z-1902-2026, Z-1908-2026, Z-1906-2026, Z-1900-2026, Z-1905-2026, Z-1898-2026, Z-1899-2026, Z-1904-2026, Z-1909-2026
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
- OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 23 March 2026
- Reason
- Potential for detachment of a distal tip component of the device during use.
- Distribution
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1854-2026, Z-1851-2026, Z-1853-2026, Z-1852-2026
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Ongoing Class II Medical devices
- Recall started
- 27 February 2026
- Reason
- Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1694-2026, Z-1695-2026
- Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device asse
- Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL-SLS Model/Catalog Number: TFL-SLS containing TFL-CSLU Product Description: An electricity powered device assembly whi
Ongoing Class II Medical devices
- Recall started
- 25 February 2026
- Reason
- Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
- Distribution
- Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia, China, Singapore, Korea, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1642-2026, Z-1643-2026, Z-1640-2026, Z-1638-2026, Z-1639-2026, Z-1644-2026, Z-1641-2026
- Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulatio
- Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920000PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. C
- Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alterna
- Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to
- Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3006 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are inten
- Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulat
- Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm l
Ongoing Class II Medical devices
- Recall started
- 12 February 2026
- Reason
- The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1610-2026, Z-1613-2026, Z-1612-2026, Z-1611-2026
- Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
- Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
- Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
- Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Ongoing Class II Medical devices
- Recall started
- 29 January 2026
- Reason
- Potential for rubber fragment detachment during use.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1488-2026, Z-1489-2026
- Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
- Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluid
Ongoing Class I Medical devices
- Recall started
- 16 January 2026
- Reason
- Issue with software algorithm which may lead to overpressure events.
- Distribution
- Nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1354-2026, Z-1353-2026, Z-1352-2026
- Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdo
- Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abd
- Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdomi
Ongoing Class II Medical devices
- Recall started
- 8 January 2026
- Reason
- Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
- Distribution
- International distribution in the country of Canada, Germany, Singapore, Australia, and India.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1494-2026
- Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An asse
Ongoing Class II Medical devices
- Recall started
- 7 January 2026
- Reason
- Devices which did not undergo thermoforming could deform and lose performance.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1290-2026, Z-1287-2026, Z-1271-2026, Z-1273-2026, Z-1289-2026, Z-1296-2026, Z-1270-2026, Z-1288-2026, Z-1297-2026, Z-1286-2026, Z-1278-2026, Z-1275-2026 and 18 more
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using h
- Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewir
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewir
- Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using
- Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using h
- Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using
- Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using
- and 22 more product lines
Ongoing Class II Medical devices
- Recall started
- 14 November 2025
- Reason
- Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1479-2026, Z-1477-2026, Z-1478-2026
- Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device
- Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromec
- Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromec
Ongoing Class II Medical devices
- Recall started
- 11 November 2025
- Reason
- Complaints of the ceramic tip of the resection sheath breaking have been received.
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1454-2026, Z-1442-2026, Z-1450-2026, Z-1445-2026, Z-1455-2026, Z-1446-2026, Z-1447-2026, Z-1439-2026, Z-1444-2026, Z-1448-2026, Z-1452-2026, Z-1449-2026 and 8 more
- Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
- Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
- Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
- Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
- Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
- Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
- Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
- Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
- and 12 more product lines
Ongoing Class I Medical devices
- Recall started
- 30 October 2025
- Reason
- Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
- Distribution
- US-wide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0570-2026
- Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Ongoing Class II Medical devices
- Recall started
- 22 October 2025
- Reason
- Firm is initiating a removal due to continued reports of adverse events.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1371-2026, Z-1378-2026, Z-1373-2026, Z-1381-2026, Z-1375-2026, Z-1377-2026, Z-1382-2026, Z-1372-2026, Z-1374-2026, Z-1380-2026, Z-1379-2026, Z-1376-2026
- Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
- Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
- Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
- Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
- Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
- Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
- Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
- Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 17 October 2025
- Reason
- Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
- Distribution
- US Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0572-2026
- Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate ne
Ongoing Class II Medical devices
- Recall started
- 14 October 2025
- Reason
- Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0579-2026
- Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light sourc
Ongoing Class II Medical devices
- Recall started
- 8 October 2025
- Reason
- The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0452-2026
- Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmen
Ongoing Class II Medical devices
- Recall started
- 6 October 2025
- Reason
- Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
- Distribution
- Worldwide distribution - US Nationwide and the countries of GU, and MP.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0483-2026, Z-0482-2026
- Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been desig
- Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an
Ongoing Class I Medical devices
- Recall started
- 11 September 2025
- Reason
- Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0065-2026, Z-0067-2026, Z-0064-2026, Z-0047-2026, Z-0055-2026, Z-0046-2026, Z-0048-2026, Z-0062-2026, Z-0050-2026, Z-0059-2026, Z-0053-2026, Z-0056-2026 and 11 more
- EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
- BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
- OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
- BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
- BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
- and 15 more product lines
Ongoing Class I Medical devices
- Recall started
- 6 August 2025
- Reason
- Potential for undetected, deformed a-traumatic tips.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2484-2025
- ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are
Ongoing Class II Medical devices
- Recall started
- 25 July 2025
- Reason
- Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2338-2025, Z-2339-2025
- Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator
- Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and
Ongoing Class II Medical devices
- Recall started
- 18 June 2025
- Reason
- Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Distribution
- International distribution to the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2143-2025, Z-2142-2025, Z-2146-2025, Z-2141-2025, Z-2144-2025, Z-2145-2025, Z-2140-2025, Z-2139-2025
- Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
- Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen whi
- Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instrume
Ongoing Class II Medical devices
- Recall started
- 6 May 2025
- Reason
- Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1922-2025, Z-1921-2025, Z-1923-2025, Z-1920-2025
- Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX94
- Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Sy
- Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-
- Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to inc
Ongoing Class II Medical devices
- Recall started
- 5 May 2025
- Reason
- Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (International) countries to: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Benin, Bolivia, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Croatia, Denmark, Dominican Republic, Egypt, El S
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1911-2025
- Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Ongoing Class II Medical devices
- Recall started
- 4 April 2025
- Reason
- Preset treatment parameters are not consistently being used in accordance with the IFU.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1715-2025
- Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural
Ongoing Class I Medical devices
- Recall started
- 15 January 2025
- Reason
- Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1071-2025
- Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201
Ongoing Class I Medical devices
- Recall started
- 18 December 2024
- Reason
- Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0905-2025
- Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and
Ongoing Class II Medical devices
- Recall started
- 16 December 2024
- Reason
- Potential for distal tip tearing of the Mechanical Lithotriptor V.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0962-2025
- LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Ongoing Class II Medical devices
- Recall started
- 25 November 2024
- Reason
- The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
- Distribution
- US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0996-2025, Z-1000-2025, Z-0993-2025, Z-0999-2025, Z-1001-2025, Z-0995-2025, Z-0998-2025, Z-0994-2025, Z-1002-2025, Z-1003-2025, Z-0997-2025
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423730 Software Ve
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423510 Software Vers
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Ver
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Vers
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Ver
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424030 Software Vers
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Vers
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Pr
- and 3 more product lines
Ongoing Class II Medical devices
- Recall started
- 19 November 2024
- Reason
- Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
- Distribution
- AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0707-2025
- Duravent Silicone Ventilation Tube. Model Number: 240075.
Ongoing Class II Medical devices
- Recall started
- 31 October 2024
- Reason
- High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0620-2025
- EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Ongoing Class II Medical devices
- Recall started
- 24 September 2024
- Reason
- Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention
- Distribution
- OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0232-2025
- Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assess
Ongoing Class II Medical devices
- Recall started
- 18 September 2024
- Reason
- To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
- Distribution
- Domestic: US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0498-2025
- Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used wi
Ongoing Class II Medical devices
- Recall started
- 13 September 2024
- Reason
- Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0351-2025
- Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
Ongoing Class II Medical devices
- Recall started
- 13 September 2024
- Reason
- Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
- Distribution
- Worldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA, TN, VA, WI; and Foreign OUS to countries of: CA, DE, IN, SG, Latin America.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0225-2025
- EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of th
Ongoing Class II Medical devices
- Recall started
- 13 September 2024
- Reason
- Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
- Distribution
- Distribution US nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1437-2026
- Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Ongoing Class II Medical devices
- Recall started
- 11 September 2024
- Reason
- Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0364-2025
- Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324B
Ongoing Class II Medical devices
- Recall started
- 4 September 2024
- Reason
- There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0264-2025
- Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Ongoing Class II Medical devices
- Recall started
- 23 August 2024
- Reason
- During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0229-2025
- Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Ongoing Class II Medical devices
- Recall started
- 21 August 2024
- Reason
- It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0181-2025
- Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
Ongoing Class II Medical devices
- Recall started
- 13 August 2024
- Reason
- The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0134-2025, Z-0135-2025
- Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
- Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS
Ongoing Class II Medical devices
- Recall started
- 1 July 2024
- Reason
- Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2540-2024, Z-2542-2024, Z-2541-2024
- The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visual
- The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visual
- The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visual
Ongoing Class II Medical devices
- Recall started
- 21 June 2024
- Reason
- Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2415-2024
- ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C
Ongoing Class II Medical devices
- Recall started
- 31 May 2024
- Reason
- Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2504-2024, Z-2506-2024, Z-2505-2024
- Soltive Premium SuperPulsed Laser System, Model TFL-PLS
- Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
- Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Ongoing Class II Medical devices
- Recall started
- 24 April 2024
- Reason
- A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits
- Distribution
- Worldwide distribution - US Nationwide and the countries of Germany, Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2233-2024
- EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operatin
Ongoing Class II Medical devices
- Recall started
- 18 April 2024
- Reason
- The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
- Distribution
- US Nationwide distribution in the state of NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2029-2024
- OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Ongoing Class II Medical devices
- Recall started
- 3 April 2024
- Reason
- Potential for distal end of the sheath to break off during a procedure.
- Distribution
- Domestic: Nationwide Distribution; Foreign: Australia, Canada, Germany, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1888-2024
- InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
Ongoing Class II Medical devices
- Recall started
- 7 March 2024
- Reason
- Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1701-2024, Z-1699-2024, Z-1700-2024
- POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/
- POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/
- POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/
Ongoing Class II Medical devices
- Recall started
- 1 March 2024
- Reason
- Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1548-2024, Z-1547-2024
- Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L
- Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L
Ongoing Class II Medical devices
- Recall started
- 17 February 2024
- Reason
- A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1222-2026, Z-1223-2026
- Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with m
- Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece
Ongoing Class II Medical devices
- Recall started
- 29 January 2024
- Reason
- A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
- Distribution
- Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1384-2024, Z-1385-2024
- SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
- SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Ongoing Class II Medical devices
- Recall started
- 16 January 2024
- Reason
- Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a risk of infection or sepsis.
- Distribution
- Domestic US distribution nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1009-2024
- Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and
Ongoing Class II Medical devices
- Recall started
- 16 January 2024
- Reason
- Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU
- Distribution
- International distribution to the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1368-2024
- InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPO
Ongoing Class II Medical devices
- Recall started
- 11 January 2024
- Reason
- Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1210-2024, Z-1208-2024, Z-1205-2024, Z-1209-2024, Z-1207-2024, Z-1214-2024, Z-1206-2024, Z-1213-2024, Z-1212-2024, Z-1211-2024
- Colonoscope, Model Number PCF-H190DL.
- Colonoscope, Model Number CF-Q180AL.
- Colonoscope, Model Number CF-H180AL.
- Colonoscope, Model Number PCF-H180AL.
- Colonoscope, Model Number CF-HQ190L.
- Colonoscope, Model Number PCF-Q180AL.
- Colonoscope, Model Number CF-HQ190I.
- Colonoscope, Model Number PCF-HQ190L.
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 5 January 2024
- Reason
- The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
- Distribution
- International distribution only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1481-2024
- Hemostasis Probe, Model: CD-B622LA
Ongoing Class II Medical devices
- Recall started
- 15 December 2023
- Reason
- The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1167-2024
- ESG PK CUTTING FORCEPS, 5MM, 33CM
Ongoing Class II Medical devices
- Recall started
- 11 December 2023
- Reason
- The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1004-2024
- Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Ongoing Class II Medical devices
- Recall started
- 8 December 2023
- Reason
- Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1071-2024
- Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator
Ongoing Class II Medical devices
- Recall started
- 4 December 2023
- Reason
- The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
- Distribution
- US Nationwide. Global Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0716-2024, Z-0717-2024
- Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
- Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Ongoing Class II Medical devices
- Recall started
- 4 December 2023
- Reason
- Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
- Distribution
- Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0718-2024
- SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Ongoing Class II Medical devices
- Recall started
- 1 December 2023
- Reason
- Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0748-2024
- SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS
Ongoing Class II Medical devices
- Recall started
- 20 November 2023
- Reason
- Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0644-2024, Z-0645-2024
- OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other anc
- OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancil
Ongoing Class II Medical devices
- Recall started
- 10 November 2023
- Reason
- Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- Distribution
- Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0939-2024, Z-0943-2024, Z-0933-2024, Z-0936-2024, Z-0938-2024, Z-0940-2024, Z-0941-2024, Z-0934-2024, Z-0942-2024, Z-0944-2024, Z-0935-2024, Z-0937-2024
- EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
- EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
- EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880
- EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
- EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
- EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
- EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
- EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
- and 4 more product lines
Ongoing Class II Medical devices
- Recall started
- 6 November 2023
- Reason
- Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0697-2024
- Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary e
Ongoing Class I Medical devices
- Recall started
- 12 October 2023
- Reason
- There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
- Distribution
- US Nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0194-2024, Z-0193-2024, Z-0189-2024, Z-0191-2024, Z-0192-2024, Z-0190-2024
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
- EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
- BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
- EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
Ongoing Class II Medical devices
- Recall started
- 2 October 2023
- Reason
- Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
- Distribution
- Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0288-2024
- EVIS EXERA III Gastrointestinal Videoscope
Ongoing Class II Medical devices
- Recall started
- 2 October 2023
- Reason
- Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
- Distribution
- US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0568-2024
- ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of
Ongoing Class II Medical devices
- Recall started
- 28 September 2023
- Reason
- Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of OUS: EMEA, Japan and Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0557-2024
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Ongoing Class II Medical devices
- Recall started
- 25 September 2023
- Reason
- Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
- Distribution
- Domestic: Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1375-2024
- Insufflation unit, UHI-4.
Ongoing Class I Medical devices
- Recall started
- 22 September 2023
- Reason
- There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0075-2024
- Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Ongoing Class II Medical devices
- Recall started
- 14 September 2023
- Reason
- Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0056-2025
- EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis,
Ongoing Class II Medical devices
- Recall started
- 12 September 2023
- Reason
- Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0108-2024, Z-0109-2024
- THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic an
- THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and
Ongoing Class II Medical devices
- Recall started
- 10 August 2023
- Reason
- Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
- Distribution
- Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2664-2023, Z-2663-2023, Z-2659-2023, Z-2661-2023, Z-2662-2023, Z-2660-2023
- Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362
- Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked B
- Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System
- Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5
- Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx I
- Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/
Ongoing Class II Medical devices
- Recall started
- 27 July 2023
- Reason
- Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2502-2023, Z-2503-2023, Z-2501-2023, Z-2490-2023, Z-2491-2023, Z-2500-2023, Z-2499-2023, Z-2494-2023, Z-2504-2023, Z-2492-2023, Z-2497-2023, Z-2496-2023 and 3 more
- Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
- Olympus Bronchovideoscope, Models BF-3C160.
- Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
- Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
- Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
- Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
- Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
- Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
- and 7 more product lines
Ongoing Class II Medical devices
- Recall started
- 27 July 2023
- Reason
- Recent reports of patient infection.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2467-2023
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Ongoing Class II Medical devices
- Recall started
- 20 July 2023
- Reason
- IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
- Distribution
- US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TX, UT, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2480-2023
- Visera Hysterovideoscope Olympus HYF Type V
Ongoing Class II Medical devices
- Recall started
- 12 July 2023
- Reason
- The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2447-2023
- The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20,
Ongoing Class I Medical devices
- Recall started
- 8 June 2023
- Reason
- There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2012-2023, Z-2017-2023, Z-2015-2023, Z-2014-2023, Z-2011-2023, Z-2013-2023, Z-2016-2023
- Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
- Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190
- Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
- Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
- Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
- Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150
- Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
Ongoing Class II Medical devices
- Recall started
- 8 June 2023
- Reason
- Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2413-2023
- HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C
Ongoing Class II Medical devices
- Recall started
- 26 May 2023
- Reason
- Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2341-2023, Z-2343-2023, Z-2344-2023, Z-2340-2023, Z-2342-2023
- Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
- Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
- Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
- VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
- Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Ongoing Class II Medical devices
- Recall started
- 19 May 2023
- Reason
- Dilator tips may break in the package and in patients during surgical procedures.
- Distribution
- Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2401-2023
- UroPass Ureteral Access Sheaths, 5 pieces/box
Ongoing Class II Medical devices
- Recall started
- 15 May 2023
- Reason
- Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2267-2023, Z-2264-2023, Z-2262-2023, Z-2263-2023, Z-2266-2023, Z-2269-2023, Z-2265-2023, Z-2268-2023
- Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-
- Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362on
- Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are c
- Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362oncho
- Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic
- Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362oncho
- Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic
- Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brIN
Ongoing Class II Medical devices
- Recall started
- 4 May 2023
- Reason
- Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1987-2023, Z-1988-2023, Z-1989-2023, Z-1990-2023
- Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
- Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
- Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
- Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
Ongoing Class II Medical devices
- Recall started
- 18 April 2023
- Reason
- The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1613-2023
- Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
Ongoing Class III Medical devices
- Recall started
- 31 March 2023
- Reason
- Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
- Distribution
- Natiowide Foreign: Canada, Germany
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1615-2023, Z-1616-2023
- ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointes
- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX
Ongoing Class II Medical devices
- Recall started
- 23 February 2023
- Reason
- There have been complaints that the clip did not come out of the tube sheath during the procedure.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1418-2023
- Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L
Ongoing Class II Medical devices
- Recall started
- 21 December 2022
- Reason
- A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1132-2023
- EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
Ongoing Class II Medical devices
- Recall started
- 13 December 2022
- Reason
- A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device
- Distribution
- FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1103-2023
- SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Ongoing Class II Medical devices
- Recall started
- 4 November 2022
- Reason
- An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.
- Distribution
- US Nationwide domestic distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0424-2023
- HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Ongoing Class II Medical devices
- Recall started
- 16 September 2022
- Reason
- Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0078-2023
- Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Ongoing Class II Medical devices
- Recall started
- 12 August 2022
- Reason
- An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
- Distribution
- Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1814-2022, Z-1813-2022, Z-1815-2022
- Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
- Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
- Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Ongoing Class II Medical devices
- Recall started
- 7 July 2022
- Reason
- Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment
- Distribution
- US Nationwide distribution in the states of AL, NM.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1514-2022
- ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Terminated Class II Medical devices
- Recall started
- 26 May 2022
- Terminated
- 5 February 2025
- Reason
- Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
- Distribution
- Nationwide distribution in the US. Foreign distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1296-2022
- SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 2
Ongoing Class II Medical devices
- Recall started
- 22 April 2022
- Reason
- Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
- Distribution
- US Nationwide distribution in the states of AL, FL, NC, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1275-2022
- EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Terminated Class II Medical devices
- Recall started
- 22 April 2022
- Terminated
- 13 March 2024
- Reason
- A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
- Distribution
- US Nationwide distribution in the state of KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1274-2022
- Colonovideoscope Model CF-H180AL
Ongoing Class II Medical devices
- Recall started
- 20 April 2022
- Reason
- Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
- Distribution
- CA FL MA MD MI NJ OH PR WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1264-2022, Z-1263-2022, Z-1262-2022
- Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
- Olympus URETERO-RENO FIBERSCOPE Model: URF-P6
- Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Terminated Class II Medical devices
- Recall started
- 31 March 2022
- Terminated
- 25 July 2024
- Reason
- Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1122-2022
- Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Ongoing Class II Medical devices
- Recall started
- 25 March 2022
- Reason
- The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.
- Distribution
- US Nationwide distribution in the state of AZ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1116-2022
- Olympus Uretero-reno videoscope, Model No. URF-V2
Ongoing Class II Medical devices
- Recall started
- 18 March 2022
- Reason
- GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1034-2022
- Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Ongoing Class II Medical devices
- Recall started
- 8 March 2022
- Reason
- Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1047-2022, Z-1048-2022, Z-1046-2022, Z-1049-2022
- BF-3C160: EVIS EXERA Bronchovideoscope
- BF-MP160F: EVIS EXERA Bronchofibervideoscope
- BF-MP60: OES Bronchofiberscope
- BF-1TQ180: EVIS EXERA II Bronchovideoscope
Ongoing Class II Medical devices
- Recall started
- 23 December 2021
- Reason
- Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
- Distribution
- US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0551-2022
- Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
Terminated Class II Medical devices
- Recall started
- 13 December 2021
- Terminated
- 26 December 2023
- Reason
- The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0638-2022
- OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Ongoing Class II Medical devices
- Recall started
- 2 November 2021
- Reason
- Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0379-2022
- EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Terminated Class II Medical devices
- Recall started
- 21 September 2021
- Terminated
- 8 September 2023
- Reason
- Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more difficult, introducing the risk of trapping the small bowel/viscera in the bag at closure resulting in patient injury.
- Distribution
- US Nationwide distribution to states of: AL, CA, CT, FL, IL, MD, MI, MN, MO, NE, NY, OH, OK, OR, PA, SC, UT, VA, WA, WI, and WV ; and International (foreign) distribution to: Europe.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0176-2022
- ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic sur
Terminated Class II Medical devices
- Recall started
- 17 August 2021
- Terminated
- 12 January 2024
- Reason
- A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
- Distribution
- US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2497-2021
- EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Terminated Class II Medical devices
- Recall started
- 16 August 2021
- Terminated
- 11 March 2024
- Reason
- The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- Distribution
- Domestic distribution nationwide. Product also distributed globally.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2566-2021, Z-2572-2021, Z-2565-2021, Z-2570-2021, Z-2567-2021, Z-2564-2021, Z-2568-2021, Z-2573-2021, Z-2569-2021, Z-2571-2021
- BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
- BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
- BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
- BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
- BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
- BF-N20 OES Bronchofiberscope, Model No. BF-N20
- BF-P60 OES Bronchofiberscope, Model No. BF-P60
- BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 3 August 2021
- Terminated
- 10 January 2023
- Reason
- Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2423-2021
- Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL O
Terminated Class II Medical devices
- Recall started
- 30 June 2021
- Terminated
- 26 January 2024
- Reason
- Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
- Distribution
- US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2294-2021
- Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or witho
Terminated Class II Medical devices
- Recall started
- 9 June 2021
- Terminated
- 17 February 2023
- Reason
- Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2380-2021
- Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunctio
Terminated Class II Medical devices
- Recall started
- 28 January 2021
- Terminated
- 13 March 2024
- Reason
- Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315).
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Japan, Europe, Australia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1292-2021
- Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancilla
Terminated Class II Medical devices
- Recall started
- 16 October 2020
- Terminated
- 7 June 2022
- Reason
- A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
- Distribution
- Worldwide distribution - US Nationwide distribution. Model Name ------------ Quantity distributed in U.S. GF-UC140P-AL5 ------------- 1,297 devices GF-UCT150-AL5 ------------- 564 devices GF-UCT180 -------------------- 3,145 devices GF-UM20 ----------------------- 31 device
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0498-2021, Z-0505-2021, Z-0507-2021, Z-0501-2021, Z-0503-2021, Z-0500-2021, Z-0506-2021, Z-0502-2021, Z-0499-2021, Z-0504-2021
- Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
- Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
- Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.
- Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
- Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy acces
- Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation
- Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
- Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy access
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 31 August 2020
- Terminated
- 14 February 2024
- Reason
- The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.
- Distribution
- Worldwide distribution - US Nationwide and International.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3017-2020
- Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documen
Terminated Class II Medical devices
- Recall started
- 31 August 2020
- Terminated
- 6 December 2022
- Reason
- The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage and displacement of the rubber on the bending section during surgical procedures.
- Distribution
- US Nationwide Distribution in states of: AK, AZ, CA, FL, GA, IL, LA, MA, ME, MI, MN, MS, NC, NM, NJ, NY, OR, SC, TN, WA, and WI; and International to: Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0119-2021
- Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagno
Terminated Class II Medical devices
- Recall started
- 14 July 2020
- Terminated
- 7 September 2021
- Reason
- Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below
- Distribution
- CA , FL , GA , PA Foreign: New Zealand , Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2814-2020, Z-2813-2020
- Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
- Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Terminated Class II Medical devices
- Recall started
- 5 May 2020
- Terminated
- 18 September 2020
- Reason
- Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
- Distribution
- US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2292-2020
- ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Terminated Class II Medical devices
- Recall started
- 23 April 2020
- Terminated
- 9 October 2024
- Reason
- A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
- Distribution
- Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2197-2020
- OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Terminated Class II Medical devices
- Recall started
- 23 March 2020
- Terminated
- 30 November 2021
- Reason
- There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1762-2020, Z-1763-2020
- Olympus Pleuravideoscope, Model LTF-160
- Olympus Pleuravideoscope, Model LTF-240
Ongoing Class II Medical devices
- Recall started
- 12 September 2019
- Reason
- Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0159-2020
- Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
Terminated Class II Medical devices
- Recall started
- 10 June 2019
- Terminated
- 10 July 2020
- Reason
- WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds.
- Distribution
- Nationwide domestic distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1983-2019
- Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm, Model. No. MAJ-1664
Terminated Class II Medical devices
- Recall started
- 1 April 2019
- Terminated
- 9 June 2020
- Reason
- There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.
- Distribution
- The products were distributed US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2148-2019
- Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end o
Terminated Class II Medical devices
- Recall started
- 17 December 2018
- Terminated
- 18 November 2020
- Reason
- The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
- Distribution
- US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1009-2019, Z-1010-2019, Z-1008-2019, Z-1007-2019
- Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
- Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
- Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
- Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Terminated Class II Medical devices
- Recall started
- 8 August 2018
- Terminated
- 17 May 2022
- Reason
- The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
- Distribution
- The products were distributed US nationwide and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3305-2018, Z-3310-2018, Z-3289-2018, Z-3303-2018, Z-3284-2018, Z-3288-2018, Z-3298-2018, Z-3308-2018, Z-3293-2018, Z-3301-2018, Z-3302-2018, Z-3306-2018 and 18 more
- Bronchovideoscope BF-XP160F
- Rhino Laryngo scope ENF-VT2
- Bronchovideoscope BF-240
- Ultrasonic Bronchoscope BF-UC160F-OL8
- Bronchofiberscope F-1T160
- Bronchovideoscope F-1TQ180
- Bronchovideoscope BF-P240
- Bronchovideoscope BF-XT160
- and 22 more product lines
Terminated Class II Medical devices
- Recall started
- 11 May 2018
- Terminated
- 5 May 2020
- Reason
- Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2269-2018, Z-2270-2018
- Olympus JF-140F duodenoscopes (Model NumberJF-140F)
- Olympus JF-160F duodenoscopes (Model NumberJF-160F)
Terminated Class II Medical devices
- Recall started
- 17 January 2018
- Terminated
- 4 December 2019
- Reason
- Potential breakage of the endoscope s insertion tube bending section during surgical procedures
- Distribution
- US Nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2518-2018
- Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
Terminated Class II Medical devices
- Recall started
- 17 January 2018
- Terminated
- 4 December 2019
- Reason
- Breakage of the endoscope's insertion tube bending section during surgical procedures.
- Distribution
- US Nationwide. Canada and Mexico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2520-2018, Z-2519-2018
- Uretero-reno fiberscope URF-P6RP6
- Uretero-reno fiberscope URF-P6
Terminated Class II Medical devices
- Recall started
- 18 August 2017
- Terminated
- 7 July 2020
- Reason
- Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missing pieces, and delamination of the adhesive have also been reported. In one case, a fragment of the adhesive was detected inside a patient's urethra during a procedure and was retrieved without injury to the patient. The manufacturer, Olympus Winter & lbe GmbH ("OWi") has determined that adhesive can be dislodged during the intended use of the cystoscopy bridge or working insert, e.g., when inserting an instrument through the working channel. As a result, a fragment of the adhesive may fall inside the patient's bladder, urethra or uterus and would need to be retrieved, extending the length of the procedure or requiring additional surgical treatment. The adhesive is used to seal gaps inside the working channel of the cystoscopy bridges and working inserts. In 2013, the adhesive used until then was discontinued and had to be replaced. Current investigations revealed that the durability of the new adhesive is insufficient
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0696-2018
- A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two way" (Lots 146W to 174W) Product Usage: A20975A: Working insert for endoscopic d
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.