{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211085", "product_res_number": "Z-0688-2025", "event_date_initiated": "2024-11-15", "event_date_posted": "2024-12-18", "recall_status": "Open, Classified", "res_event_number": "95741", "product_code": "PUB", "product_description": "Brand Name: K-Systems\nProduct Name: G85 Mini Incubator\nModel/Catalog Number: K22074\nSoftware Version: N/A\nProduct Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.\nComponent: No", "code_info": "Version or Model: K22074; Primary DI Number: 00888937025057; Serial Numbers: 2244KH01 , 2244KH02 , 2244KH03 , 2244KH04 , 2244KH05 , 2244KH06 , 2244KH07 , 2244KH08 , 2244KH09 , 2244KH10 , 2313KH01 , 2313KH02 , 2313KH03 , 2313KH04 , 2313KH05 , 2313KH06 , 2313KH07 , 2313KH08 , 2313KH09 , 2313KH10 , 2320KH21 , 2320KH22 , 2320KH23 , 2320KH24 , 2320KH25 , 2320KH26 , 2320KH27 , 2320KH28 , 2320KH29 , 2320KH30 , 2321KH16 , 2321KH17 , 2321KH18 , 2321KH19 , 2321KH20.", "firm_fei_number": "1216677", "recalling_firm": "CooperSurgical, Inc.", "address_1": "95 Corporate Dr", "city": "Trumbull", "state": "CT", "postal_code": "06611-1350", "additional_info_contact": "Karen Gienau\n001-203-4054510", "reason_for_recall": "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.", "root_cause_description": "Process change control", "action": "On November 15, 2024 URGENT MEDICAL DEVICE RECALL emails were sent to customers. On November 20, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers.\tActions that should be taken by the customer/user/distributor in order to prevent risks for patients or users:\n \nG85 Mini Incubators with serial numbers listed in the Appendix are impacted and require repair. \n\n1.\tInspect your inventory, identify, and discontinue use.\n2.\tComplete the attached Urgent Medical Device Recall Response Form and return the form to CooperSurgical as indicated at the top of the form. Note: Please complete and return the form even if you do not have any affected product in your inventory so that we may document receipt of this Urgent Medical Device Recall. \n3.\tContact your local Service Representative to arrange a repair at no cost to you. \n\nT45, T47, R65, and G73 with serial numbers listed in the Appendix may be impacted and require inspection to determine the need for repair.\n\n1.\tInspect your inventory, identify, and discontinue use.\n2.\tComplete the attached Urgent Medical Device Recall Response Form and return the form to CooperSurgical as indicated at the top of the form. Note: Please complete and return the form even if you do not have any affected product in your inventory so that we may document receipt of this Urgent Medical Device Recall. \n3.\tContact your local Service Representative to arrange an inspection of the affected product. If your product is affected, the product will be repaired at no cost to you. 6.\tActions planned by CooperSurgical to correct the problem\nCooperSurgical is currently investigating this issue and determined a field action notice to customers is needed to inspect and repair all affected products in the field.\nCooperSurgical is committed to high-quality, safe, and effective products. This corrective action has been initiated to ensure this failure mode does not reoccur and future potential patient harm can be avoided. \nIf you need any further", "product_quantity": "37 units", "distribution_pattern": "States: NC, NJ, TX, VA, IL, NY, CA, PA\n\nPlease note: The countries below, excluding Iraq, all consider these devices to be \"lab equipment\", not medical devices and are not subject to classification or recall guidelines. \n\nCountries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZA", "openfda": { "k_number": [ "K191020" ], "registration_number": [ "1221433", "3002465911", "9616263", "3025301749", "3007459332", "3009747883", "3003244268", "3004871219", "3023235140", "3009204541", "3034286704", "3009065312", "3033918993", "3017170064", "3014353045", "3031594904", "1216677", "3014755376", "3000184820", "3017838619", "9680654" ], "fei_number": [ "1221433", "3002465911", "3003751666", "3025301749", "3007459332", "3009747883", "3003244268", "3023235140", "3009204541", "3034286704", "3009065312", "3033918993", "3017170064", "3014353045", "1216677", "3014755376", "3000184820", "3017838619", "3007530363", "3031594904", "3001229191" ], "device_name": "Accessory, Assisted Reproduction, Exempt", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.6120", "device_class": "2" } } ] }