Every recall we track for CooperSurgical, Inc — 59 in all — plus the complaints and injury reports the public filed about them.
CooperSurgical recalls HSG Procedure Tray model 6050T with non-sterile iodine pouches incorrectly labeled as sterile. This could lead to infection risks during hysterosalpingography procedures.
CooperSurgical recalls Endosee System Convenience Kit (model ES-TRAY) due to non-sterile iodine pouches labeled as sterile. Affected units include specific lot numbers. Consumers should check their kit for correct labeling.
K-Systems R65 Trolley models K24012 may overheat during use in fertility clinics. The device could alarm but may still exceed safe temperatures for reproductive materials. Affected units have specific serial numbers.
CooperSurgical recalls K-Systems G73 Dry Bath Incubators (model K22065) due to potential overheating. The incubator may exceed set temperatures, triggering alarms but risking improper temperature control for reproductive materials.
CooperSurgical recalls K-Systems incubators that may overheat, causing temperature control failures. Affected units could risk improper biological material storage during assisted reproduction procedures.
CooperSurgical recalls K-Systems T47 Warming Plates with model K23054 that may overheat, causing temperature exceedance. Affected units have specific serial numbers. Contact for remedy.
CooperSurgical recalls K-Systems G85 Mini Incubators with model K22074 that may overheat during assisted reproduction procedures, causing potential temperature control issues.
CooperSurgical recalls Silver-Plated Copper Sims Uterine Sound (Part 64-6: 00888937017762) due to incorrect part number laser marking during manufacturing. This may cause confusion in identifying the correct device.
CooperSurgical recalls stainless steel Sims Uterine Sound (part 64-6:601) due to incorrect laser marking during manufacturing. Affected units may have wrong part numbers and should be checked.
CooperSurgical recalls Origio Sperm Wash Medium Pack of Five 60ml bottles due to potential low sodium pyruvate concentration affecting gamete development. No remedy specified in official notice.
CooperSurgical recalls Origio Sperm Wash Medium Pack of Ten 10ml bottles due to potential low sodium pyruvate concentration affecting gamete development. No remedy specified in official notice.
CooperSurgical recalls Origio Sperm Wash Medium Pack of Five 60ml bottles due to potential low sodium pyruvate concentration affecting gamete development. No remedy specified in the recall notice.
CooperSurgical recalls three embryo culture bottle models (20mL, 50mL, 100mL) after reports of impaired embryo development. Affected units may need replacement to prevent issues during early embryonic growth.
CooperSurgical recalls CloseSure System XL kits with incorrect component descriptions on Tyvek lid. Affected kits may have missing parts; contact for replacement.
CooperSurgical recalls 60mL Global Total LP embryo culture medium that may lack required protein for embryo development. Affected units have specific lot numbers and reference codes.
CooperSurgical recalls BIOPSY MEDIUM 10ML (Lot 220506-006557) due to potential embryo degradation from incorrect medium. Affected units may cause embryo damage during IVF procedures.
CooperSurgical recalls NEO-fit Neonatal Endotracheal Tube Grip (Part 42-2540) due to loose metal clips that have been ingested by patients or caused throat lacerations.
CooperSurgical recalls humidifier bottles and syringe filter kits for BT37 Mark I incubators due to potential sterile barrier breaches causing embryo contamination. Affected units include specific lot numbers and expiration dates.
CooperSurgical recalls humidifier bottles and syringe filter kits for BT37 Mark II incubators due to potential sterile barrier breaches causing embryo contamination. Affected units include specific lot numbers.
CooperSurgical recalls LifeGlobal Fast Freeze Thawing Kit Model GFT5-055 due to Spanish instructions incorrectly stating 5-minute air thaw instead of 5 seconds. This could lead to improper freezing.
CooperSurgical recalls VITRIGUARD carrier clear cryopreservation storage devices with model 43782001 due to potential compromised barrier seals that could introduce contamination.
CooperSurgical recalls H/S Catheter Set FR 5 Model 61-4005S for potential detachment during procedures, causing delays. Affected units may have incorrect bonding materials.
CooperSurgical recalls H/S ELLI:5 FR Set for possible detachment during hysterosalpingography procedures. This could delay treatment. Affected units have specific serial numbers and model.
CooperSurgical recalls H/S ELLIPTOSPHERE CATH : Incorrect bonding material may cause detachment, delaying procedures. Affected units have model 61-3005 and specific serial numbers.
CooperSurgical recalls PARAGARD T380A intrauterine copper contraceptives due to non-sterility risk. One unit per carton with insertion tube and white rod is affected. No remedy specified in official notice.
CooperSurgical recalls LEEP Precision Generator 120V (Part LP-20-120) due to risk of coagulation failure during use, potentially requiring medical intervention for bleeding. Affected units have specific serial numbers.
CooperSurgical recalls Quantum 2000 Electrosurgical Generators with part number 909075-05. These devices may fail to coagulate tissue during surgery, requiring medical intervention to control bleeding.
CooperSurgical recalls LEEP Precision Integrated System (120V, part number LP-10-120) due to potential failure of coagulate function with Hand Switch, which may lead to prolonged surgical procedures requiring medical intervention for bleeding control.
Cooper Surgical recalls LEEP PRECISION Generator 220V (part LP-20-220) due to potential coagulation failure during use, requiring medical intervention for bleeding. Affected units have specific serial numbers.
CooperSurgical recalls Quantum 2000 Electrosurgical Generators with specific part and serial numbers due to a safety hazard. Affected units may pose risks during medical procedures.
CooperSurgical recalls LEEP Precision Integrated System (220V) with part numbers LP-10-220. Failure to coagulate tissue during use may cause prolonged bleeding requiring medical intervention.
CooperSurgical recalls Quantum 2000 Electrosurgical Generators with part number 909075 due to potential coagulation failure during surgery, requiring medical intervention for bleeding.
CooperSurgical recalls Oxygen Sensor Model K54019-2 used in G185 & G210 Incubators and G603 Work Chambers. Sensors may display incorrect oxygen levels, risking embryo loss during storage.
CooperSurgical recalls 10mm x 10mm Square Wallach Loop Electrodes (P/N 909131) that were incorrectly packaged with round electrodes. This packaging error may lead to incorrect use during medical procedures.
CooperSurgical recalls Koh Cup 3.5cm model (P/N 34131-04) due to incorrect packaging. This model is not the required 3.0cm size and may cause improper use during vaginal procedures.
CooperSurgical recalls Milex Gellhorn Flexible pessaries with incorrect stem length that may cause improper fit or displacement. Affected models include specific reference numbers and lots.
CooperSurgical recalls MediCult Vitrification Cooling Media Model 12284001F due to label printing error showing wrong product type. Affected units sold in 2023 with specific lot number.
CooperSurgical recalls Os Finder Cervical Dilators (Part 1176) due to mislabeling. Products may show incorrect part numbers on packaging. Consumers should check labels and contact the company for details.
CooperSurgical recalls sterile cervical dilator sets with potentially compromised pouch seals. Affected units from specific lot number may pose infection risk if used improperly.
Cooper Surgical recalls 10-unit boxes of Wallace Artificial Insemination Catheters (Model AIC18JP) due to incorrect 5-year expiry date instead of 3-year safety expiry. This affects fertility treatments and requires immediate verification.
Cooper Surgical recalls Endosee Cannula (ESPX5) with potential unsealed pouches in two lots. Affected units may have pouches that could leak, causing contamination. Stop using and contact for replacement.
CooperSurgical recalls Quantam 2000 Electrosurgical Generators with specific part numbers and serial ranges due to potential failure to cut, coagulate, or blend during procedures when foot pedal is used.
CooperSurgical recalls Quantum 2000 Electrosurgical Generators with part numbers 909075, 909075-05, and 909075-05W that may stop cutting, coagulating, or blending during surgery if the foot pedal is used.
CooperSurgical recalls Quantam 2000 Electrosurgical Generators with specific part numbers and serial ranges due to potential failure to cut, coagulate, or blend during procedures when foot pedal is used.
CooperSurgical recalls Embryology Heated Plate models 6-70-807, 6-70-807-A, and 6-70-807-B due to touchpad malfunction after cleaning. This affects IVF lab equipment used for embryo temperature control.
CooperSurgical recalls LEEP Return Patient Pads with reversed expiration dates on outer boxes. This could lead to expired pads being used in procedures. Affected lots: 201809125 and 2: 201809135.
CooperSurgical recalls TransWarmer Warming Infant Transport Mattress Model 20421 due to risk of skin burns if used with incubators. Some units lack updated safety instructions.
CooperSurgical recalls LEEP Precision Integrated System 120V and Generator models LP-10-120 and LP-20-120 due to potential failure of cut, coagulate, or blend functions when using the foot pedal.
CooperSurgical recalls Advincula Delineator uterine manipulators with Ultem Plastic Soft Cup size 2.5 cm (Part No. AD750SC-KE25) due to potential cracking during use, which could cause lacerations. Affected units were sold starting Lot 017-19.
CooperSurgical recalls Advincula Delineator size 3.0 cm soft cups due to potential cracking from excessive compressions, which could cause lacerations during uterine procedures.
CooperSurgical recalls LEEP Precision Integrated System 120V models with potentially incorrect fuses that could lead to fire. Affected units were sold starting in 2018. Consumers should contact CooperSurgical for details.
CooperSurgical recalls ICSI MicroPipettes with part number MICC001-30-B1.0 due to missing 30-degree bend. Affected units sold in 2023.
CooperSurgical recalls Retractor System Elastic Stays (parts 3314-lG, 3316-lG, 3550-lG) due to possible compromised sterile pouch seals increasing infection risk. Affected lots include 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, and 248871.
CooperSurgical recalls Colpo-Pneumo Occluder Part CPO-6 with specific lot numbers due to potential infection risk from compromised sterile pouch seals. Affected patients should contact the manufacturer for guidance.
CooperSurgical recalls 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar (Model 90: 223333) due to incorrect packaging. This may cause improper surgical use. Affected users should contact CooperSurgical for details.
CooperSurgical recalls Fischer Cone Biopsy Excisor Medium (5/Box) model 900-151 due to incorrect packaging. Consumers should check product details to determine if affected.
