North Haven, CT, United States
Covidien, LP recalls
96 recalls recorded since 2018, most recently on 24 June 2026. 63 are listed as ongoing. Status and classification are as published by the FDA.
Recalls96
Ongoing (FDA)63
Terminated or completed33
Class I (FDA)11
Ongoing Class II Medical devices
- Recall started
- 24 June 2026
- Reason
- Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
- Distribution
- US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2919-2026, Z-2922-2026, Z-2918-2026, Z-2921-2026, Z-2920-2026
- V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT D
- Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
- V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30C
- Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
- Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Ongoing Class II Medical devices
- Recall started
- 13 May 2026
- Reason
- The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Canada, Col
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2950-2026
- EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring syste
Ongoing Class II Medical devices
- Recall started
- 23 April 2026
- Reason
- Temperature probe devices lack FDA clearance.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2273-2026, Z-2272-2026, Z-2271-2026
- Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
- Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
- Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Ongoing Class II Medical devices
- Recall started
- 23 April 2026
- Reason
- Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
- Distribution
- U.S. Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Virgin Islands. The c
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2653-2026
- Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006
Ongoing Class II Medical devices
- Recall started
- 15 April 2026
- Reason
- Due to customer complaint regarding incorrect display box labeling.
- Distribution
- Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2261-2026
- COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are dou
Ongoing Class II Medical devices
- Recall started
- 15 April 2026
- Reason
- The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
- Distribution
- Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2281-2026
- Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Ongoing Class II Medical devices
- Recall started
- 30 January 2026
- Reason
- Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1557-2026
- HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital
Ongoing Class II Medical devices
- Recall started
- 25 September 2025
- Reason
- A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0486-2026, Z-0485-2026
- Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
- Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Ongoing Class II Medical devices
- Recall started
- 23 June 2025
- Reason
- Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
- Distribution
- Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS, IN, IL, TN, MO, IA, OK, WI, AK, NY, MD, AL, WV, GA, NC, AR, WA, SD, KY, DE, NJ, UT, NV, MA, MT, GU, NE, LA, HI, OR, RI, NH, ND, NM, ME, CT, DC, WY and the countries of Algeria, Andor
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2151-2025
- Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
Ongoing Class I Medical devices
- Recall started
- 21 May 2025
- Reason
- Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
- Distribution
- Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, S
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1915-2025
- Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-
Ongoing Class I Medical devices
- Recall started
- 26 February 2025
- Reason
- Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
- Distribution
- OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1390-2025
- Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Ongoing Class II Medical devices
- Recall started
- 19 September 2024
- Reason
- Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China, France, French Guiana, Germany, Greece, Guadeloupe, India, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Spain and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0257-2025
- Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm
Ongoing Class I Medical devices
- Recall started
- 9 July 2024
- Reason
- Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Virgin Islan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2636-2024, Z-2637-2024
- McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
- McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
Ongoing Class II Medical devices
- Recall started
- 9 July 2024
- Reason
- IFU update to address device's battery handling information.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, US Virgin I
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2717-2024
- Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
Ongoing Class I Medical devices
- Recall started
- 24 June 2024
- Reason
- Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway
- Distribution
- US: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR, TX, WI, PA, CO, MI, NM, RI, VA, DC, VT, NC, NH, WV, NV, IA. OUS: Argentina, Australia, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Czech Republic
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2446-2024
- Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 5
Ongoing Class II Medical devices
- Recall started
- 25 April 2024
- Reason
- Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Canada, Denmark, Germa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2038-2024
- EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Ongoing Class II Medical devices
- Recall started
- 15 April 2024
- Reason
- Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
- Distribution
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1891-2024
- Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Ongoing Class II Medical devices
- Recall started
- 15 March 2024
- Reason
- Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1634-2024, Z-1635-2024
- Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and
- Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN
Ongoing Class II Medical devices
- Recall started
- 28 February 2024
- Reason
- The potential for trocar seal disengagement when using mesh products incorrectly with the device.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, H
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1470-2024, Z-1468-2024, Z-1467-2024, Z-1471-2024, Z-1466-2024, Z-1465-2024, Z-1469-2024
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
- Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
Ongoing Class II Medical devices
- Recall started
- 21 February 2024
- Reason
- Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1330-2024
- Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Ongoing Class II Medical devices
- Recall started
- 14 February 2024
- Reason
- Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
- Distribution
- Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1457-2024, Z-1458-2024
- Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
- Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Ongoing Class II Medical devices
- Recall started
- 25 January 2024
- Reason
- One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery.
- Distribution
- International distribution in the countries of Portugal and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1697-2024
- Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation.
Ongoing Class II Medical devices
- Recall started
- 9 January 2024
- Reason
- manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
- Distribution
- US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal R
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1731-2024, Z-1732-2024
- Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
- Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
Ongoing Class II Medical devices
- Recall started
- 21 December 2023
- Reason
- Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
- Distribution
- Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, Fra
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0844-2024, Z-0845-2024
- Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
- Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X3
Ongoing Class II Medical devices
- Recall started
- 16 November 2023
- Reason
- Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, IL, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0986-2024
- AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30
Ongoing Class II Medical devices
- Recall started
- 16 November 2023
- Reason
- Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
- Distribution
- Worldwide distribution - US: Nationwide and surrounding territories.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0631-2024
- Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Ongoing Class I Medical devices
- Recall started
- 28 September 2023
- Reason
- Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.
- Distribution
- Unknown
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0144-2024
- Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Ongoing Class II Medical devices
- Recall started
- 22 August 2023
- Reason
- Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Thailand, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2632-2023
- Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Ongoing Class II Medical devices
- Recall started
- 22 August 2023
- Reason
- Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.
- Distribution
- US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2651-2023
- Puritan Bennett Cuff Pressure Manager, REF: 180-03
Ongoing Class II Medical devices
- Recall started
- 10 August 2023
- Reason
- Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.
- Distribution
- US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia Czech Republic Denmark Finland France French Guiana Germany Guadeloupe Hong Kong Hungary Ireland Israel Italy Kazakhstan Ko
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0168-2024, Z-0169-2024
- McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
- McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Ongoing Class I Medical devices
- Recall started
- 28 June 2023
- Reason
- Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
- Distribution
- US Nationwide - Worldwide Distribution Foreign: Argentina Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Canada Cayman Islands China Costa Rica Czech Republic Denmark Dominican Republic Finland France French Polynesia Germany Greece Hungary India Iran, Islamic Republic Of Ireland Ital
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2372-2023, Z-2388-2023, Z-2391-2023, Z-2383-2023, Z-2371-2023, Z-2384-2023, Z-2379-2023, Z-2390-2023, Z-2376-2023, Z-2369-2023, Z-2378-2023, Z-2380-2023 and 13 more
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
- MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
- MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
- MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637
- and 17 more product lines
Ongoing Class II Medical devices
- Recall started
- 2 June 2023
- Reason
- Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2282-2023
- Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Ongoing Class II Medical devices
- Recall started
- 22 May 2023
- Reason
- Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.
- Distribution
- International distribution in the country of Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2008-2023
- Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Ongoing Class I Medical devices
- Recall started
- 24 March 2023
- Reason
- A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.
- Distribution
- Worldwide - US Nationwide distribution including in the states of PR, CA, FL, MN, PA, AZ, IL, TN, OH, MI, GA, KS, HI, MD, AK, NY, NE, IA, OK, VA, ND, MO, NC, SC, KY, OR, IN, WA, TX, WI, CT, MA, WV, CO, VT, NJ, SD, AR, AL, MS, LA, DE, MT, WY, DC, UT, NV, NH, RI, ID, NM, ME and the countries of Algeri
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1357-2023
- Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT F
Ongoing Class II Medical devices
- Recall started
- 22 March 2023
- Reason
- There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
- Distribution
- Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1464-2023, Z-1465-2023, Z-1463-2023
- VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
- VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
- VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Ongoing Class II Medical devices
- Recall started
- 1 March 2023
- Reason
- Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
- Distribution
- Worldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA, NC, NY, OH, WA; and countries of: Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1387-2023, Z-1388-2023, Z-1390-2023, Z-1389-2023
- Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
- Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG
- Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
- Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
Ongoing Class II Medical devices
- Recall started
- 10 February 2023
- Reason
- Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
- Distribution
- U.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA, and WV O.U.S.: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1318-2023
- COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are indicated for airway management by oral/nasal intubation of the trachea for anesthesi
Ongoing Class II Medical devices
- Recall started
- 25 January 2023
- Reason
- Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, It
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1228-2023
- Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Ongoing Class II Medical devices
- Recall started
- 11 January 2023
- Reason
- Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
- Distribution
- US Distribution to states of: CA, GA, NY and OUS Foreign distribution to countries of: Armenia, Belgium, France, Germany, Israel, Japan, Luxembourg, Romania, Spain, Switzerland and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1183-2023
- Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3
Ongoing Class I Medical devices
- Recall started
- 7 December 2022
- Reason
- There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Distribution
- Worldwide distribution. US nationwide including Guam, USVI, and Puerto Rico; Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, Italy, Jamaica, K
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0877-2023
- MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm,
Ongoing Class II Medical devices
- Recall started
- 2 December 2022
- Reason
- Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
- Distribution
- US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Geor
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1178-2023, Z-1172-2023, Z-1182-2023, Z-1181-2023, Z-1177-2023, Z-1176-2023, Z-1174-2023, Z-1180-2023, Z-1173-2023, Z-1175-2023, Z-1179-2023
- Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 888619
- Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88
- Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
- Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X
- Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
- Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0
- Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF*
- Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541
- and 3 more product lines
Ongoing Class II Medical devices
- Recall started
- 23 November 2022
- Reason
- The product is labeled with the incorrect expiration date.
- Distribution
- Foreign Distribution: Hong Kong
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0955-2023
- COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Ongoing Class II Medical devices
- Recall started
- 28 September 2022
- Reason
- Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Canada Canary Islands Chile Croatia Cyprus Denmark Egypt Finland France Germany Greece Hungary Ireland Israel Italy Jordan Kazakhstan Kuwait Lithuania Luxembourg Mexico Netherlands New Zealand Norway Poland Portugal
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0200-2023, Z-0201-2023
- Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
- Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
Ongoing Class II Medical devices
- Recall started
- 19 August 2022
- Reason
- Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
- Distribution
- Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1775-2022
- Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Ongoing Class I Medical devices
- Recall started
- 8 June 2022
- Reason
- There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1312-2022, Z-1315-2022, Z-1317-2022, Z-1318-2022, Z-1320-2022, Z-1316-2022, Z-1313-2022, Z-1314-2022, Z-1319-2022
- Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 7 June 2022
- Reason
- Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
- Distribution
- AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1467-2022
- TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Ongoing Class II Medical devices
- Recall started
- 13 May 2022
- Reason
- The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1322-2022
- EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
Ongoing Class II Medical devices
- Recall started
- 22 December 2021
- Reason
- Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue monitoring and transition into the calibration screen without an audible alarm.
- Distribution
- The devices were distributed to the following US states: CA, CO, FL, IL, KY, MA, OH, TN, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0514-2022
- SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Ongoing Class II Medical devices
- Recall started
- 17 December 2021
- Reason
- The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0557-2022
- Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
Terminated Class II Medical devices
- Recall started
- 6 December 2021
- Terminated
- 11 May 2023
- Reason
- Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.
- Distribution
- Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0495-2022
- LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Ongoing Class II Medical devices
- Recall started
- 12 November 2021
- Reason
- Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
- Distribution
- Brazil
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0332-2022
- Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Terminated Class I Medical devices
- Recall started
- 4 November 2021
- Terminated
- 9 July 2024
- Reason
- Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0351-2022, Z-0343-2022, Z-0342-2022, Z-0352-2022, Z-0348-2022, Z-0341-2022, Z-0339-2022, Z-0346-2022, Z-0340-2022, Z-0347-2022, Z-0338-2022, Z-0349-2022 and 4 more
- Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
- Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
- Puritan Bennett 980 Series Ventilator, 980U1ENASAA
- Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
- Puritan Bennett 980 Series Ventilator, 980X1ENNISB
- Puritan Bennett 980 Series Ventilator, 980S3ENDICU
- Puritan Bennett 980 Series Ventilator, 980A3ENNISB
- Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
- and 8 more product lines
Terminated Class II Medical devices
- Recall started
- 29 September 2021
- Terminated
- 13 February 2025
- Reason
- The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.
- Distribution
- No domestic distribution. Foreign distribution to Hong Kong and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0210-2022
- Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Terminated Class II Medical devices
- Recall started
- 23 June 2021
- Terminated
- 28 January 2025
- Reason
- Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
- Distribution
- US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2240-2021
- Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Ongoing Class II Medical devices
- Recall started
- 28 May 2021
- Reason
- This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2373-2021, Z-2374-2021, Z-2369-2021, Z-2371-2021, Z-2361-2021, Z-2370-2021, Z-2368-2021, Z-2358-2021, Z-2367-2021, Z-2359-2021, Z-2372-2021, Z-2365-2021 and 6 more
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
- Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
- Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
- Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
- Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
- Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
- and 10 more product lines
Ongoing Class II Medical devices
- Recall started
- 29 April 2021
- Reason
- The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1868-2021, Z-1867-2021, Z-1866-2021, Z-1869-2021
- Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22
- Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard
- Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors
- HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm conne
Terminated Class II Medical devices
- Recall started
- 23 March 2021
- Terminated
- 15 May 2024
- Reason
- Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure to Ethylene Oxide retained in the pouch
- Distribution
- AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1419-2021
- Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resec
Ongoing Class II Medical devices
- Recall started
- 5 March 2021
- Reason
- Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.
- Distribution
- Domestic: AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, UT, WA, WI, WV. Foreign: Canada, Japan, Taiwan, Australia, New Zealand, Indonesia, Thailand, Singapore, Malaysia, Philippines, Bahamas, Brazil, Chile, El Salvador
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1411-2021
- Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
Terminated Class II Medical devices
- Recall started
- 4 March 2021
- Terminated
- 12 July 2024
- Reason
- Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1383-2021, Z-1385-2021, Z-1384-2021
- Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
- Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
- Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
Ongoing Class II Medical devices
- Recall started
- 26 February 2021
- Reason
- The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1334-2021, Z-1335-2021
- CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
- BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
Terminated Class II Medical devices
- Recall started
- 13 January 2021
- Terminated
- 14 February 2023
- Reason
- incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia recurrence
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of MA and the countries of France, French Guiana, Germany, Luxembourg, Spain, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1142-2021
- Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparoscopic or posterior open procedures Item Code: TECT1510AL
Completed Class II Medical devices
- Recall started
- 23 November 2020
- Reason
- May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis
- Distribution
- Nationwide Foreign: Canada, Albania Armenia Australia Austria Belarus Belgium Bosnia And Herzegovina Cyprus Czech Republic Egypt Estonia France Germany Greece Hungary Iceland Israel Italy Japan Jordan Korea Kuwait Latvia Libyan Arab Jamahiriya Lithuania Malaysia Martini
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0748-2021, Z-0747-2021
- Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number:
- Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V
Ongoing Class II Medical devices
- Recall started
- 16 November 2020
- Reason
- The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0515-2021
- Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
Ongoing Class II Medical devices
- Recall started
- 16 October 2020
- Reason
- In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Bolivia, Brazil, Cayman Islands, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Jamaica, Mexico, Nicaragua, Panama, Peru, Uraguay, Honduras, Austria, Bahrain, Belgium, Bulgaria,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0425-2021
- Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1END
Ongoing Class II Medical devices
- Recall started
- 12 August 2020
- Reason
- The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
- Distribution
- Worldwide distribution - US Nationwide and Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0003-2021, Z-0009-2021, Z-0005-2021, Z-0001-2021, Z-0004-2021, Z-0007-2021, Z-0008-2021, Z-0002-2021, Z-0006-2021
- Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for
- Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatri
- Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, tra
- Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery
- Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for
- Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and c
- Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for
- Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 26 June 2020
- Reason
- This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
- Distribution
- world wide distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2769-2020, Z-2768-2020
- Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce
- Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce t
Ongoing Class II Medical devices
- Recall started
- 12 May 2020
- Reason
- The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2252-2020, Z-2254-2020, Z-2255-2020, Z-2253-2020
- Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgica
- Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects an
- Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects an
- Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgica
Terminated Class II Medical devices
- Recall started
- 30 April 2020
- Terminated
- 14 December 2023
- Reason
- Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1985-2020, Z-1991-2020, Z-1988-2020, Z-1990-2020, Z-1994-2020, Z-1987-2020, Z-1986-2020, Z-1984-2020, Z-1993-2020, Z-1989-2020, Z-1992-2020
- Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Pre
- Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor an
- Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Pr
- Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, P
- Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter S
- Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Pres
- Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
- Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
- and 3 more product lines
Terminated Class II Medical devices
- Recall started
- 10 February 2020
- Terminated
- 26 April 2024
- Reason
- Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
- Distribution
- Nationwide domestic distribution. Foreign distribution to Australia, Canada, Austria Belgium Canary Islands Czech Republic Denmark Finland France Germany Greece Hungary Italy Jordan Kazakhstan Kenya Lithuania Luxembourg North Macedonia Poland Portugal Reunion Romania Russian Fed
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1447-2020, Z-1446-2020
- Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT
- Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
Terminated Class II Medical devices
- Recall started
- 17 January 2020
- Terminated
- 29 July 2022
- Reason
- Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
- Distribution
- US Nationwide, Israel, and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1264-2020
- Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Terminated Class II Medical devices
- Recall started
- 18 December 2019
- Terminated
- 16 August 2022
- Reason
- There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1293-2020, Z-1292-2020, Z-1275-2020, Z-1280-2020, Z-1296-2020, Z-1290-2020, Z-1300-2020, Z-1276-2020, Z-1277-2020, Z-1289-2020, Z-1278-2020, Z-1291-2020 and 15 more
- Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
- Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue
- Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
- Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
- Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
- Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
- Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
- Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
- and 19 more product lines
Ongoing Class II Medical devices
- Recall started
- 17 May 2019
- Reason
- The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
- Distribution
- Nationwide domestic distribution, worldwide foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1827-2019, Z-1835-2019, Z-1832-2019, Z-1826-2019, Z-1825-2019, Z-1834-2019, Z-1830-2019, Z-1828-2019, Z-1836-2019, Z-1833-2019, Z-1829-2019, Z-1831-2019
- EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
- SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
- EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
- EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
- and 4 more product lines
Terminated Class II Medical devices
- Recall started
- 29 April 2019
- Terminated
- 9 January 2024
- Reason
- The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
- Distribution
- Nationwide domestic distribution. Foreign distribution to Canada, Australia, New Zealand, Latin America, and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1955-2019
- MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 881714200
Terminated Class II Medical devices
- Recall started
- 13 March 2019
- Terminated
- 23 April 2020
- Reason
- Sterilization method used was not consistent with the labeling and the approved sterilization method
- Distribution
- Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1211-2019, Z-1212-2019, Z-1213-2019
- Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for in
- Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedure
- Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COL
Terminated Class II Medical devices
- Recall started
- 15 February 2019
- Terminated
- 24 July 2020
- Reason
- The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
- Distribution
- The products were distributed to the following US states: CA, NJ, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1041-2019
- Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Terminated Class II Medical devices
- Recall started
- 15 February 2019
- Terminated
- 17 June 2020
- Reason
- Potential for the sterile packaging to be compromised
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1020-2019
- Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urolog
Ongoing Class II Medical devices
- Recall started
- 15 November 2018
- Reason
- The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0627-2019, Z-0625-2019, Z-0626-2019
- Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete
- Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or comp
- Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or com
Terminated Class II Medical devices
- Recall started
- 5 November 2018
- Terminated
- 14 August 2020
- Reason
- The product was released into commercial distribution while subject to importation refusal.
- Distribution
- The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0656-2019
- 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Terminated Class II Medical devices
- Recall started
- 31 October 2018
- Terminated
- 26 May 2020
- Reason
- This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.
- Distribution
- Worldwide Distribution - US Nationwide and foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0597-2019
- Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illnes
Terminated Class II Medical devices
- Recall started
- 5 October 2018
- Terminated
- 7 May 2020
- Reason
- The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin. Medtronic has received, worldwide, a total of ten reports of mesh failure following use of the product in the last five years. Patients who have received a Parietex" composite parastomal mesh for the treatment of a parastomal hernia should continue to receive ongoing monitoring by their healthcare providers for the recurrence of a parastomal hernia.
- Distribution
- Worldwide distribution--US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0461-2019
- Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two
Terminated Class I Medical devices
- Recall started
- 18 September 2018
- Terminated
- 1 February 2021
- Reason
- Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
- Distribution
- Worldwide Distribution - US Nationwide Foreign: Canada Argentina Chile Japan Hong Kong Taiwan Uruguay Austria Austria Azerbaijan Belgium Bosnia And Herzegovina Bulgaria Croatia Czech Republic France Germany Greece Hungary Ireland Israel Italy Kazakhstan Kenya Kuwait Latvia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0497-2019
- Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennet
Terminated Class II Medical devices
- Recall started
- 17 August 2018
- Terminated
- 10 April 2020
- Reason
- The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0070-2019
- EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of tita
Terminated Class II Medical devices
- Recall started
- 1 August 2018
- Terminated
- 3 June 2020
- Reason
- Potential for product sterility breach due to a compromised or pinched seal defect
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0016-2019, Z-0018-2019, Z-0014-2019, Z-0017-2019, Z-0013-2019, Z-0015-2019
- Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonizatio
- Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Ongoing Class II Medical devices
- Recall started
- 26 July 2018
- Reason
- Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
- Distribution
- Nationwide Foreign: Australia, New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2958-2018
- Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
Terminated Class II Medical devices
- Recall started
- 11 July 2018
- Terminated
- 3 August 2020
- Reason
- The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
- Distribution
- The products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3207-2018, Z-3205-2018, Z-3203-2018, Z-3208-2018, Z-3206-2018, Z-3204-2018
- P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
- 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
- 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
- P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS
- 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
- TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T
Terminated Class II Medical devices
- Recall started
- 15 June 2018
- Terminated
- 8 May 2019
- Reason
- Potential proplylene glycol contamination
- Distribution
- CA, NY & TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2601-2018
- Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Terminated Class II Medical devices
- Recall started
- 9 April 2018
- Terminated
- 12 May 2020
- Reason
- There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.
- Distribution
- Worldwide Distribution - US Nationwide in the US states of : AL, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, SC, TN, TX, UT, and VA. The devices were distributed to the following foreign countries: UAE, Australia, Austria, Belgium, Bulgaria, Canada, Czech Re
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1527-2018, Z-1528-2018
- EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapl
- EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapl
Terminated Class II Medical devices
- Recall started
- 15 March 2018
- Terminated
- 11 December 2019
- Reason
- Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
- Distribution
- Worldwide Distribution in the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Swede, Switzerland and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2427-2018
- LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatic
Terminated Class II Medical devices
- Recall started
- 13 December 2017
- Terminated
- 14 April 2020
- Reason
- Product reportedly shutting down during use.
- Distribution
- Worldwide Distribution: US (Nationwide).
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1237-2018
- Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in o
Terminated Class II Medical devices
- Recall started
- 21 November 2017
- Terminated
- 10 July 2020
- Reason
- Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia. and to the cou
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1208-2018
- Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861
Terminated Class II Medical devices
- Recall started
- 12 October 2017
- Terminated
- 12 May 2020
- Reason
- This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.
- Distribution
- U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1130-2018
- Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF
Terminated Class II Medical devices
- Recall started
- 21 September 2017
- Terminated
- 26 September 2018
- Reason
- Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0640-2018
- GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to ra
Terminated Class II Medical devices
- Recall started
- 15 September 2017
- Terminated
- 19 December 2018
- Reason
- The device cartridge disengaged during use due to manufacturing error.
- Distribution
- Internationally, including Japan. No USA Customers
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0908-2018
- Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resec
Terminated Class II Medical devices
- Recall started
- 13 September 2017
- Terminated
- 28 June 2019
- Reason
- Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0636-2018
- Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Ongoing Class II Medical devices
- Recall started
- 7 August 2017
- Reason
- The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
- Distribution
- Nationwide including PR, Canada, China
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0560-2018, Z-0559-2018, Z-0561-2018, Z-0556-2018, Z-0558-2018, Z-0557-2018
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
- Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
Terminated Class II Medical devices
- Recall started
- 17 July 2017
- Terminated
- 14 September 2018
- Reason
- Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.
- Distribution
- U.S., Gov Accts, and foreign countries: PA, PR, CO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0534-2018
- Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body c
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.