← Every firm
CooperSurgical, Inc. FDA Recalls
40 recalls on file across devices, drugs, 3 of them Class I and 36 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model NuClass IAug 11, 2026Potential to exhibit a loose connection between the flexible |
| INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. ModClass IAug 11, 2026Potential to exhibit a loose connection between the flexible |
| HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterogClass IIJun 11, 2025The HSG Procedure Trays and Endosee System Convenience Kits |
| Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.Class IIJun 11, 2025The HSG Procedure Trays and Endosee System Convenience Kits |
| Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience KitClass IIJun 11, 2025The HSG Procedure Trays and Endosee System Convenience Kits |
| Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product DescriptiClass IINov 15, 2024The warming surfaces or incubator well temperatures of the l |
| Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A PrClass IINov 15, 2024The warming surfaces or incubator well temperatures of the l |
| Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product DesClass IINov 15, 2024The warming surfaces or incubator well temperatures of the l |
| Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product DeClass IINov 15, 2024The warming surfaces or incubator well temperatures of the l |
| Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product DesClass IINov 15, 2024The warming surfaces or incubator well temperatures of the l |
| Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electClass IINov 15, 2024The warming surfaces or incubator well temperatures of the l |
| Stainless Steel Sims Uterine Sound, Part Number 64-601Class IIJul 31, 2024During the manufacturing process the devices were laser-mark |
| Silver-Plated Copper Sims Uterine Sound, Part Number 64-600Class IIJul 31, 2024During the manufacturing process the devices were laser-mark |
| Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010AClass IIFeb 16, 2024Low concentration of sodium pyruvate in the wash could compr |
| Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060DClass IIFeb 16, 2024Low concentration of sodium pyruvate in the wash could compr |
| Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060AClass IIFeb 16, 2024Low concentration of sodium pyruvate in the wash could compr |
| global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: CultClass IIDec 20, 2023The firm has become aware of a sudden increase in complaints |
| Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: RClass IIAug 29, 2023Incorrect component descriptions within the "Contents" secti |
| Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference NumClass IIFeb 13, 2023It has come to CooperSurgical's attention that the affected |
| BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantatiClass IIDec 15, 2022The affected product may contain a medium other than the Bio |
| NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540Class IIOct 20, 2022Firm has received 11 complaints involving a loose or detache |
| Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)Class IIAug 12, 2022There is a potential breach to the sterile barrier containin |
| Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The MaClass IIAug 12, 2022There is a potential breach to the sterile barrier containin |
| LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055Class IIJun 13, 2022There was translation error in the Spanish version of the IF |
| VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed oClass IIApr 1, 2022Products in this lot may have compromised barrier seals, int |
| Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or HysteroClass IIMar 31, 2022Incorrect bonding material used for assembly of the catheter |
| CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during HysClass IIMar 31, 2022Incorrect bonding material used for assembly of the catheter |
| Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or HysterosonClass IIMar 31, 2022Incorrect bonding material used for assembly of the catheter |
| PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white roClass IFeb 4, 2022Non-sterility |
| Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05WClass IISep 29, 2021XXX |
| LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120Class IISep 29, 2021Coagulate function may not operate with the use of the Hand |
| Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075Class IISep 29, 2021Coagulate function may not operate with the use of the Hand |
| Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05Class IISep 29, 2021Coagulate function may not operate with the use of the Hand |
| LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220Class IISep 29, 2021Coagulate function may not operate with the use of the Hand |
| LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120Class IISep 29, 2021Coagulate function may not operate with the use of the Hand |
| LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220Class IISep 29, 2021Coagulate function may not operate with the use of the Hand |
| Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for usClass IIJun 30, 2021Units are displaying output readings that differ from the me |
| CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Disposable Universal Electrodes, LOOP electrodesClass IIApr 30, 2021The affected Wallach LOOP Electrodes were incorrectly packag |
| The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade pClass IIApr 23, 2021The affected Koh Cup were incorrectly packaged with a 3.5cm |
| Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4"Class IIJan 21, 2021The affected Milex Gellhorn pessaries were incorrectly manuf |