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CooperSurgical Recalls
84 recalls on record · June 18, 2014 to July 30, 2025 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
July 30, 2025Medical DevicesFDA
CooperSurgical, Inc. recalls Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Hazard: 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.
July 30, 2025Medical DevicesFDA
CooperSurgical, Inc. recalls Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Hazard: 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.
July 30, 2025Medical DevicesFDA
CooperSurgical, Inc. recalls HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterog
Hazard: 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.
December 25, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Pr
Hazard: 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.
December 25, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Descripti
Hazard: 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.
December 25, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Des
Hazard: 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.
December 25, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Des
Hazard: 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.
December 25, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product De
Hazard: 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.
December 25, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An elect
Hazard: 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.
October 2, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Hazard: Low concentration of sodium pyruvate in the wash could compromise gamete development
October 2, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
Hazard: Low concentration of sodium pyruvate in the wash could compromise gamete development
October 2, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
Hazard: Low concentration of sodium pyruvate in the wash could compromise gamete development
October 2, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601
Hazard: During the manufacturing process the devices were laser-marked with the incorrect part number.
October 2, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Hazard: During the manufacturing process the devices were laser-marked with the incorrect part number.
February 21, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Cult
Hazard: 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.
February 14, 2024Medical DevicesFDA
CooperSurgical, Inc. recalls Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: R
Hazard: Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
December 13, 2023Medical DevicesFDA
CooperSurgical, Inc. recalls CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hys
Hazard: 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
December 13, 2023Medical DevicesFDA
CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hystero
Hazard: 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
December 13, 2023Medical DevicesFDA
CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysteroson
Hazard: 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
April 12, 2023Medical DevicesFDA
CooperSurgical, Inc. recalls Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Num
Hazard: 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.
February 8, 2023Medical DevicesFDA
CooperSurgical, Inc. recalls BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantati
Hazard: 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.
November 16, 2022Medical DevicesFDA
CooperSurgical, Inc. recalls NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Hazard: 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.
October 5, 2022Medical DevicesFDA
CooperSurgical, Inc. recalls Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Hazard: 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.
October 5, 2022Medical DevicesFDA
CooperSurgical, Inc. recalls Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Ma
Hazard: 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.
July 27, 2022Medical DevicesFDA
CooperSurgical, Inc. recalls LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Hazard: 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.
May 25, 2022Medical DevicesFDA
CooperSurgical, Inc. recalls VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed o
Hazard: Products in this lot may have compromised barrier seals, introducing a risk to sterility.
February 23, 2022DrugsFDA
CooperSurgical, Inc recalls PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white ro
Hazard: Non-sterility
November 24, 2021Medical DevicesFDA
CooperSurgical, Inc. recalls Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
Hazard: XXX
November 24, 2021Medical DevicesFDA
CooperSurgical, Inc. recalls Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
Hazard: 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.
November 24, 2021Medical DevicesFDA
CooperSurgical, Inc. recalls Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
Hazard: 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.