{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196587", "product_res_number": "Z-0223-2023", "event_date_initiated": "2022-10-20", "event_date_posted": "2022-11-10", "recall_status": "Open, Classified", "res_event_number": "91047", "product_code": "JAY", "product_description": "NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540", "code_info": "Lot/Serial Number\tUDI-DI (GTIN-14 - not yet added to GUDID database)\n272992\t00888937016659\n269476\t00888937016659\n269477\t00888937016659\n269478\t00888937016659\n269479\t00888937016659\n269480\t00888937016659\n269482\t00888937016659\n269483\t00888937016659\n274957\t00888937016659\n274958\t00888937016659\n274960\t00888937016659\n274961\t00888937016659\n286859\t00888937016659\n286861\t00888937016659\n286863\t00888937016659\n292881\t00888937016659\n292883\t00888937016659\n292888\t00888937016659\n292889\t00888937016659\n292900\t00888937016659\n292901\t00888937016659\n292903\t00888937016659\n296236\t00888937016659\n296238\t00888937016659\n297033\t00888937016659\n297034\t00888937016659\n297035\t00888937016659\n298049\t00888937016659\n298055\t00888937016659\n298054\t00888937016659\n298056\t00888937016659\n298062\t00888937016659\n303771\t00888937016659\n303772\t00888937016659\n303950\t00888937016659\n304053\t00888937016659\n304363\t00888937016659\n305019\t00888937016659\n305020\t00888937016659\n307724\t00888937016659\n306339\t00888937016659\n306341\t00888937016659\n307728\t00888937016659\n307726\t00888937016659\n307730\t00888937016659\n308591\t00888937016659\n309910\t00888937016659\n309912\t00888937016659\n313142\t00888937016659\n311533\t00888937016659\n314675\t00888937016659\n315626\t00888937016659\n315810\t00888937016659\n318970\t00888937016659\n316866\t00888937016659\n320400\t00888937016659", "firm_fei_number": "1216677", "recalling_firm": "CooperSurgical, Inc.", "address_1": "95 Corporate Dr", "city": "Trumbull", "state": "CT", "postal_code": "06611-1350", "additional_info_contact": "Daniel Heuer\n203-601-5200 Ext. 3300", "reason_for_recall": "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.", "root_cause_description": "Under Investigation by firm", "action": "On October 20, 2022, the firm notified affected customers via \"URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE\" letters dated 10/7/2022.\n\nCustomers were instructed to quarantine all affected product and complete the appropriate version of the attached form (Customer Acknowledgement Form or Distributor Acknowledgement Form). Once completed, return the form to CooperSurgical as indicated at the top of the form. Note: Even if you do not have any affected product in your inventory (or have not distributed any affected product to customers), please complete and return the enclosed form so that we may document receipt of this FSN. \n\nCooperSurgical will then arrange for the return of the affected product at no additional cost to the customer. Customers will receive a credit for returned product.\n\nIf you have any questions, please feel free to reach us at 203-601-5200 ext. 3300 or recall@coopersurgical.com.", "product_quantity": "220,500 devices", "distribution_pattern": "Worldwide distribution: US (Nationwide) including Puerto Rico; and countries (foreign) of: Australia, Bahrain, Belgium, Bulgaria, Canada, Colombia, Cyprus, Ecuador, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Malaysia, Malta, Netherlands, New Zealand, Saudi Arabia, Singapore, Turkey, Philippines, Qatar, United Arab Emirates, and United Kingdom.", "openfda": { "k_number": [ "K770631", "K833361", "K873491", "K770628", "K944988", "K833374", "K790410", "K781509", "K792148", "K850924", "K840844", "K834089", "K860583", "K850309", "K802675", "K791781", "K834265", "K833332", "K832946" ], "registration_number": [ "", "2025917", "3009596133", "3004604967", "3012494290", "3010889742", "3026309274", "8010939", "3009162386", "3030220356", "3009747810", "3000247987", "9680215", "3030595965", "3007648359", "2938401", "2085602", "2080309", "1226711", "8043316", "1314417", "3011137372", "3006534321", "3014437893", "9614084", "2022648", "1722095", "3013188547", "3019793765", "3013496867", "3026391023", "9617604", "9680455", "3010621964", "2032112", "2023337", "8030673", "3005273623", "2182345", "2529776", "3010595915", "3012956249", "9615827", "3012542015", "3001313714", "3005285078", "8022265", "3038611387", "3012187635", "3007573469", "3045058049", "2025816", "3013195449", "3001415205", "2518436", "3011197191", "3003102481", "3020777588", "2028807", "3004365956", "3014301596", "3010359088", "1216677", "3003431869", "1220908", "9611451", "3003135857", "3011854984", "3006606984", "3015142701", "3005587132", "3002807267", "9611500" ], "fei_number": [ "", "2025917", "3001084824", "3009596133", "1000115734", "3003338236", "3004604967", "3012494290", "3003076831", "3010889742", "3026309274", "3009162386", "3030220356", "3009747810", "3000247987", "3030595965", "3007648359", "2938401", "2080309", "3001104093", "1314417", "3014437893", "3006534321", "3002807293", "2022648", "3013188547", "3002808274", "3019793765", "3002808440", "3013496867", "3026391023", "3010621964", "3002861325", "2023337", "1000374126", "2182345", "3005273623", "3010595915", "3012956249", "3012542015", "3005285078", "3001620388", "3038611387", "3012187635", "3004213967", "3045058049", "3003319165", "3013195449", "2025816", "3003080079", "3001415205", "2518436", "3011197191", "3003102481", "3005747797", "3020777588", "1000117278", "3004365956", "3014301596", "3010359088", "1216677", "3003431869", "1220908", "3000210616", "3003135857", "3002806988", "3011854984", "1000121196", "3006606984", "3002558692", "3015142701", "3005587132", "3002807267" ], "device_name": "Support, Breathing Tube", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5280", "device_class": "1" } } ] }