Trumbull, CT, United States
CooperSurgical, Inc. recalls
38 recalls recorded since 2018, most recently on 11 August 2026. 16 are listed as ongoing. Status and classification are as published by the FDA.
Recalls38
Ongoing (FDA)16
Terminated or completed22
Class I (FDA)2
Ongoing Class I Medical devices
- Recall started
- 11 August 2026
- Reason
- Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
- Distribution
- Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3140-2026, Z-3139-2026
- INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.
- INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.
Ongoing Class II Medical devices
- Recall started
- 11 June 2025
- Reason
- The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, 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, and Washington DC.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2137-2025, Z-2136-2025, Z-2135-2025
- Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
- Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
- HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.
Ongoing Class II Medical devices
- Recall started
- 15 November 2024
- Reason
- The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
- Distribution
- States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines. Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0688-2025, Z-0689-2025, Z-0692-2025, Z-0687-2025, Z-0690-2025, Z-0691-2025
- Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation con
- Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation cond
- Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incuba
- Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reprodu
- Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation cond
- Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions
Ongoing Class II Medical devices
- Recall started
- 31 July 2024
- Reason
- During the manufacturing process the devices were laser-marked with the incorrect part number.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain, Canada, Hong Kong, India, New Zealand, Qatar, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3189-2024, Z-3188-2024
- Stainless Steel Sims Uterine Sound, Part Number 64-601
- Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Ongoing Class II Medical devices
- Recall started
- 16 February 2024
- Reason
- Low concentration of sodium pyruvate in the wash could compromise gamete development
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3298-2024, Z-3296-2024, Z-3297-2024
- Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
- Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
- Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
Ongoing Class II Medical devices
- Recall started
- 20 December 2023
- Reason
- The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
- Distribution
- Worldwide - US Nationwide including in the states of AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WV and the countries of Canada, Brazil, Mexico, Argentina, Hong Kong, Japan, Turkey, Netherlands, Belgium, Spain, Taiwa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1089-2024
- global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
Ongoing Class II Medical devices
- Recall started
- 29 August 2023
- Reason
- Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
- Distribution
- US Nationwide distribution in the state of MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0985-2024
- Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer
Ongoing Class II Medical devices
- Recall started
- 13 February 2023
- Reason
- It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1348-2023
- Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
Ongoing Class II Medical devices
- Recall started
- 15 December 2022
- Reason
- The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo.
- Distribution
- Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria, Oman, Pakistan, Poland, Republic of North Macedonia, Saudi Arabia, Slovenia, Spain, Thailand, Turkey, Tur
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1044-2023
- BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)
Ongoing Class II Medical devices
- Recall started
- 20 October 2022
- Reason
- Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat.
- Distribution
- Worldwide distribution: US (Nationwide) including Puerto Rico; and countries (foreign) of: Australia, Bahrain, Belgium, Bulgaria, Canada, Colombia, Cyprus, Ecuador, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Malaysia, Malta, Netherlands, New Zealand, Saudi Arabia, Singapore, Turkey,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0223-2023
- NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Ongoing Class II Medical devices
- Recall started
- 12 August 2022
- Reason
- There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may result in use of an unsterilized device, which may cause contamination and degradation or loss of embryo during incubation.
- Distribution
- Domestic distribution to the following states: AL AZ CA CT DE FL GA HI IL KS MA MI MN MO NJ NY OH OR SC TX VA VT WA WI WV Foreign distribution to Barbados, Canada, Chile, Micronesia Federate, and Panama.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1823-2022, Z-1822-2022
- Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
- Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be use
Ongoing Class II Medical devices
- Recall started
- 13 June 2022
- Reason
- There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.
- Distribution
- Domestic: USA AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VT, WA, WI, International: Belgium, Canada, Croatia, Netherlands, Portugal, Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1421-2022
- LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Ongoing Class II Medical devices
- Recall started
- 1 April 2022
- Reason
- Products in this lot may have compromised barrier seals, introducing a risk to sterility.
- Distribution
- Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1108-2022
- VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Ongoing Class II Medical devices
- Recall started
- 31 March 2022
- Reason
- Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
- Distribution
- Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0502-2024, Z-0503-2024, Z-0504-2024
- Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial th
- Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial
- CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibro
Terminated Class I Drugs
- Recall started
- 4 February 2022
- Terminated
- 6 February 2023
- Reason
- Non-sterility
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0643-2022
- PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of T
Ongoing Class II Medical devices
- Recall started
- 29 September 2021
- Reason
- Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
- Distribution
- US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, R
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0261-2022, Z-0258-2022, Z-0263-2022, Z-0260-2022, Z-0257-2022, Z-0262-2022, Z-0259-2022
- Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
- LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
- Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
- LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
- LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
- Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
- LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
Terminated Class II Medical devices
- Recall started
- 30 June 2021
- Terminated
- 21 November 2022
- Reason
- Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the display is reading a target setting of 5%, an external meter is reading between 3% and 12% and the Incubator does not alarm. May result in loss of embryo during storage.
- Distribution
- Only Foreign: Bahrain, Belgium, Bulgaria, Czech Republic Denmark, Egypt, Estonia, France, Georgia, Germany, Ghana, Great Britain, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2307-2021
- Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G1
Terminated Class II Medical devices
- Recall started
- 30 April 2021
- Terminated
- 21 July 2023
- Reason
- The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode.
- Distribution
- US distribution to: CA, MD, MO, NJ, PA, and TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1847-2021
- CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodes, used for electro-excisional procedures, and for electro-fulguration procedures of the lower genita
Ongoing Class II Medical devices
- Recall started
- 23 April 2021
- Reason
- The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
- Distribution
- Domestic: UT, OH, DE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1686-2021
- The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
Terminated Class II Medical devices
- Recall started
- 21 January 2021
- Terminated
- 3 January 2024
- Reason
- The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, FL, IL, KS, MA, MI, NC, NY, PA, TN, TX, WA, & Puerto Rico. The countries of New Zealand, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1152-2021
- Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) withou
Terminated Class II Medical devices
- Recall started
- 8 September 2020
- Terminated
- 11 January 2021
- Reason
- There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.
- Distribution
- The products were distributed to China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0100-2021
- MediCult Vitrification Cooling Media, Model Number 12284001F
Terminated Class II Medical devices
- Recall started
- 3 June 2020
- Terminated
- 11 May 2021
- Reason
- Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicating that it contains a Pipet Current or Part Number MX140 and the display box indicating the correct Os FinderTM Cervical Dilators, Part Number 1176. The product in the individual product package is the correct Os Finder Cervical Dilator
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2498-2020
- COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
Terminated Class II Medical devices
- Recall started
- 9 April 2020
- Terminated
- 11 May 2021
- Reason
- The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
- Distribution
- Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2112-2020
- CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Terminated Class III Medical devices
- Recall started
- 28 February 2020
- Terminated
- 11 August 2020
- Reason
- Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.
- Distribution
- International distribution to Japan only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1713-2020
- Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washe
Terminated Class II Medical devices
- Recall started
- 13 December 2019
- Terminated
- 11 May 2021
- Reason
- Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
- Distribution
- US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WV, & WY. OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0798-2020
- ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee
Terminated Class II Medical devices
- Recall started
- 16 October 2019
- Terminated
- 30 June 2020
- Reason
- Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.
- Distribution
- US: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, ME, Ml, MT, ND, NJ, NV, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, & WV. International: China, Indonesia, South Africa, & Tanzania.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0602-2020, Z-0600-2020, Z-0601-2020
- Quantam 2000 Electrosurgical Generator, Part number 909075-05W.
- Quantam 2000 Electrosurgical Generator, Part number 909075.
- Quantam 2000 Electrosurgical Generator, Part number 909075-05.
Terminated Class III Medical devices
- Recall started
- 5 September 2019
- Terminated
- 2 September 2021
- Reason
- The touchpad may not work properly after cleaning.
- Distribution
- Worldwide distribution - including US Nationwide in the states of CA, CO, CT, GA, IL, MI, NC, NJ, PA, & WA, and countries of Canada and Denmark.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0029-2020
- Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laborat
Terminated Class III Medical devices
- Recall started
- 19 August 2019
- Terminated
- 14 July 2020
- Reason
- Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.
- Distribution
- USA: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, & WV. Distribution US nationwide, Canada, Colombia, Japan, & Malaysia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2545-2019
- LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
Terminated Class II Medical devices
- Recall started
- 8 July 2019
- Terminated
- 28 May 2020
- Reason
- The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU.
- Distribution
- Worldwide Distribution - US Nationwide in all 50 states. International distribution to Australia, Brazil, Canada, Ecuador, Germany, Gibraltar, India, Ireland, Kuwait, Macedonia, New Zealand, Oman, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, South Korea, Switzerland, United Arab Emirates, & Un
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2364-2019
- TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold st
Terminated Class II Medical devices
- Recall started
- 18 June 2019
- Terminated
- 15 June 2020
- Reason
- The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.
- Distribution
- Nationwide domestic distribution. International distribution to Canada and Costa Rica.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2057-2019
- LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
Terminated Class II Medical devices
- Recall started
- 14 June 2019
- Terminated
- 19 May 2020
- Reason
- The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.
- Distribution
- US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1978-2019, Z-1977-2019
- Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterect
- Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterect
Terminated Class II Medical devices
- Recall started
- 23 April 2019
- Terminated
- 24 April 2020
- Reason
- 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.
- Distribution
- US Nationwide Distribution in the states of CA, CT, IN, MA, MI, MN, NC, NV, NY, OH, TX, WA and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1840-2019
- LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke
Terminated Class II Medical devices
- Recall started
- 27 March 2019
- Terminated
- 1 May 2020
- Reason
- ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent
- Distribution
- Foreign: Denmark, Italy, Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1367-2019
- ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
Terminated Class II Medical devices
- Recall started
- 4 September 2018
- Terminated
- 27 May 2020
- Reason
- The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
- Distribution
- The products were distributed to the following US states: 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0098-2019
- Colpo-Pneumo Occluder, Part CPO-6
Terminated Class II Medical devices
- Recall started
- 4 September 2018
- Terminated
- 15 April 2020
- Reason
- There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
- Distribution
- Worldwide Distribution n- US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WV, and the following foreign countries of: Australia, Canada, Colombia, Czech Republic, Germany, Ireland, Israel, Italy,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3278-2018
- Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achie
Terminated Class II Medical devices
- Recall started
- 12 March 2018
- Terminated
- 8 May 2019
- Reason
- Products have been packaged with an incorrect product size.
- Distribution
- CA, SC, WI, MI, NH, MD, OH, NJ, Australia, France, Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1879-2018
- Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
Terminated Class II Medical devices
- Recall started
- 12 March 2018
- Terminated
- 8 May 2019
- Reason
- Products have been packaged with the wrong Trocar length type.
- Distribution
- Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1584-2018
- 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to p
Terminated Class II Medical devices
- Recall started
- 6 October 2017
- Terminated
- 6 February 2020
- Reason
- The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
- Distribution
- Worldwide Distribution - US Nationwide and the countries of ( Canada and England)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1131-2018
- Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. Th
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.