CooperSurgical recalls
17 official recalls and safety alerts involving CooperSurgical since 2021-11, from FDA · Device, FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with CooperSurgical or the relevant agency.
- 2026-09-30
USCooperSurgical, Inc. recalls INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers:…
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…
FDA · DeviceCooperSurgical, Inc.Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA,…Official notice →- 2025-07-30
- US
CooperSurgical, Inc. recalls Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
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.
FDA · DeviceCooperSurgical, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - 2024-12-25
- US
CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An…
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.
FDA · DeviceCooperSurgical, Inc.States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below,…Official notice → - 2024-10-02
- US
CooperSurgical, Inc. recalls Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Low concentration of sodium pyruvate in the wash could compromise gamete development
- US
CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601
During the manufacturing process the devices were laser-marked with the incorrect part number.
FDA · DeviceCooperSurgical, Inc.Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain,…Official notice → - 2024-02-21
- US
CooperSurgical, Inc. recalls global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human…
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.
FDA · DeviceCooperSurgical, Inc.Worldwide - US Nationwide including in the states of AL, AZ, CA, CO, FL, GA,…Official notice → - 2024-02-14
- US
CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard,…
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
- 2023-12-13
- US
CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures…
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
FDA · DeviceCooperSurgical, Inc.Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLANDOfficial notice → - 2023-04-12
- US
CooperSurgical, Inc. recalls Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
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…
FDA · DeviceCooperSurgical, Inc.Worldwide - US Nationwide distribution in the states of NY, UT and the…Official notice → - 2023-02-08
- US
CooperSurgical, Inc. recalls BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic…
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.
FDA · DeviceCooperSurgical, Inc.Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt,…Official notice → - 2022-11-16
- US
CooperSurgical, Inc. recalls NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
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…
FDA · DeviceCooperSurgical, Inc.Worldwide distribution: US (Nationwide) including Puerto Rico; and countries…Official notice → - 2022-10-05
- US
CooperSurgical, Inc. recalls Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
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…
FDA · DeviceCooperSurgical, Inc.Domestic distribution to the following states: AL AZ CA CT DE FL GA HI IL KS…Official notice → - 2022-07-27
- US
CooperSurgical, Inc. recalls LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
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…
FDA · DeviceCooperSurgical, Inc.Domestic: USA AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT,…Official notice → - 2022-05-25
- US
CooperSurgical, Inc. recalls VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
Products in this lot may have compromised barrier seals, introducing a risk to sterility.
FDA · DeviceCooperSurgical, Inc.Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No…Official notice → - 2022-02-23
- US
- 2021-11-24
- US
CooperSurgical, Inc. recalls Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
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FDA · DeviceCooperSurgical, Inc.US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE,…Official notice → - US
CooperSurgical, Inc. recalls Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
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…
FDA · DeviceCooperSurgical, Inc.US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE,…Official notice →