Coopersurgical recalls
Coopersurgical appears in 86 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-30.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 86 |
|---|---|
| Published | 2014-06-18 to 2026-09-30 |
| By agency | FDA Device (85), FDA Drug (1) |
| By classification | Class II (73), Class III (10), Class I (3) |
| By status | terminated (50), ongoing (36) |
| Distribution named in notices | 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, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set
FDA Device · Class I · 2026-09-30 · Coopersurgical
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… - INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
FDA Device · Class I · 2026-09-30 · Coopersurgical
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… - Endosee System Convenience Kit with IV Tube
FDA Device · Class II · 2025-07-30 · Coopersurgical
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. - Endosee System Convenience Kit
FDA Device · Class II · 2025-07-30 · Coopersurgical
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. - HSG Procedure Tray
FDA Device · Class II · 2025-07-30 · Coopersurgical
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. - Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-pow…
FDA Device · Class II · 2024-12-25 · Coopersurgical
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. - Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrical…
FDA Device · Class II · 2024-12-25 · Coopersurgical
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. - Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrica…
FDA Device · Class II · 2024-12-25 · Coopersurgical
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. - Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An e…
FDA Device · Class II · 2024-12-25 · Coopersurgical
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. - Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrical…
FDA Device · Class II · 2024-12-25 · Coopersurgical
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. - Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device…
FDA Device · Class II · 2024-12-25 · Coopersurgical
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. - Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa
FDA Device · Class II · 2024-10-02 · Coopersurgical
Reason: Low concentration of sodium pyruvate in the wash could compromise gamete development - Stainless Steel Sims Uterine Sound, Part Number 64-601
FDA Device · Class II · 2024-10-02 · Coopersurgical
Reason: During the manufacturing process the devices were laser-marked with the incorrect part number. - Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
FDA Device · Class II · 2024-10-02 · Coopersurgical
Reason: During the manufacturing process the devices were laser-marked with the incorrect part number. - Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa
FDA Device · Class II · 2024-10-02 · Coopersurgical
Reason: Low concentration of sodium pyruvate in the wash could compromise gamete development - Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A
FDA Device · Class II · 2024-10-02 · Coopersurgical
Reason: Low concentration of sodium pyruvate in the wash could compromise gamete development - global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle)
FDA Device · Class II · 2024-02-21 · Coopersurgical
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. - Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems
FDA Device · Class II · 2024-02-14 · Coopersurgical
Reason: Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays. - Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedur…
FDA Device · Class II · 2023-12-13 · Coopersurgical
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 - Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures…
FDA Device · Class II · 2023-12-13 · Coopersurgical
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 - CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or…
FDA Device · Class II · 2023-12-13 · Coopersurgical
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 - Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
FDA Device · Class II · 2023-04-12 · Coopersurgical
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 develo… - BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosi…
FDA Device · Class II · 2023-02-08 · Coopersurgical
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. - NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
FDA Device · Class II · 2022-11-16 · Coopersurgical
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 on… - Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295)
FDA Device · Class II · 2022-10-05 · Coopersurgical
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 unst… - Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
FDA Device · Class II · 2022-10-05 · Coopersurgical
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 unst… - LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
FDA Device · Class II · 2022-07-27 · Coopersurgical
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… - VITRIGUARD, CARRIER, CLEAR
FDA Device · Class II · 2022-05-25 · Coopersurgical
Reason: Products in this lot may have compromised barrier seals, introducing a risk to sterility. - PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyet…
FDA Drug · Class I · 2022-02-23 · Coopersurgical
Reason: Non-sterility - Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Device · Class II · 2021-11-24 · Coopersurgical
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 c… - Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
FDA Device · Class II · 2021-11-24 · Coopersurgical
Reason: XXX - LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
FDA Device · Class II · 2021-11-24 · Coopersurgical
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 c… - LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
FDA Device · Class II · 2021-11-24 · Coopersurgical
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 c… - LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
FDA Device · Class II · 2021-11-24 · Coopersurgical
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 c… - LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
FDA Device · Class II · 2021-11-24 · Coopersurgical
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 c… - Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
FDA Device · Class II · 2021-11-24 · Coopersurgical
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 c… - Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following in…
FDA Device · Class II · 2021-08-25 · Coopersurgical
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 do… - CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131
FDA Device · Class II · 2021-06-16 · Coopersurgical
Reason: The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode. - The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator
FDA Device · Class II · 2021-06-02 · Coopersurgical
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. - 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…
FDA Device · Class II · 2021-03-10 · Coopersurgical
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… - MediCult Vitrification Cooling Media, Model Number 12284001F
FDA Device · Class II · 2020-10-21 · Coopersurgical
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… - COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
FDA Device · Class II · 2020-07-15 · Coopersurgical
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 Di… - CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
FDA Device · Class II · 2020-06-03 · Coopersurgical
Reason: The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. - Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937…
FDA Device · Class III · 2020-04-22 · Coopersurgical
Reason: Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years. - ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code…
FDA Device · Class II · 2020-01-22 · Coopersurgical
Reason: Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5). - Quantam 2000 Electrosurgical Generator, Part number 909075-05
FDA Device · Class II · 2019-12-11 · Coopersurgical
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. - Quantam 2000 Electrosurgical Generator, Part number 909075-05W
FDA Device · Class II · 2019-12-11 · Coopersurgical
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. - Quantam 2000 Electrosurgical Generator, Part number 909075
FDA Device · Class II · 2019-12-11 · Coopersurgical
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. - 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 Freq…
FDA Device · Class III · 2019-10-09 · Coopersurgical
Reason: The touchpad may not work properly after cleaning. - LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures
FDA Device · Class III · 2019-09-25 · Coopersurgical
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.