{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198891", "product_res_number": "Z-1348-2023", "event_date_initiated": "2023-02-13", "event_date_posted": "2023-04-06", "recall_status": "Open, Classified", "res_event_number": "91794", "product_code": "MQL", "k_numbers": [ "K142991" ], "product_description": "Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060", "code_info": "UDI-DI: 00815965020433;\nLOT 221118-010694", "firm_fei_number": "1216677", "recalling_firm": "CooperSurgical, Inc.", "address_1": "95 Corporate Dr", "city": "Trumbull", "state": "CT", "postal_code": "06611-1350", "additional_info_contact": "203-601-5200", "reason_for_recall": "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 development.", "root_cause_description": "Labeling Change Control", "action": "An URGENT: VOLUNTARY MEDIA RECALL dated 1/26/23 was sent to customers.\n\nActions to be Taken:\n\nFor both CUSTOMERS and DISTRIBUTORS:\n\n\"\tInspect your stock for the Product from this lot. Lot information can be found on the box and bottle labeling.\n\no\tIf found, quarantine, and discontinue use of the Product from this lot immediately.\n\no\tPlease complete and return the appropriate enclosed Acknowledgment Form (even if you do not have the specific lot remaining in stock) to initiate our recall return process. Credit will be applied to your account to reorder replacement product, as per our recall process, with no additional cost to you or your facilities.\n\no\tThe form can be returned to CooperSurgical via email at Recall@coopersurgical.com or via fax at +1.203.601.9870\n\nPlease feel free to contact your local account manager or contact us at +1-203-601-5200 Monday Friday 09:00 17:00 EST, and follow the phone prompt to enter the ext. 3300 or via email at Recall@coopersurgical.com.\n\nIf affected Product has been distributed to customers, please select one of the following options: \n\"\tI have identified and notified all customers to whom the affected Product may have been distributed.\n\"\tI am providing a list of all customers to whom affected Product may have been distributed along with their contact information.", "product_quantity": "190 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of NY, UT and the countries of Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.", "openfda": { "k_number": [ "K983580", "K002383", "K991472", "K240605", "K081116", "K191552", "K254261", "K991393", "K031015", "K143498", "K991337", "K083509", "K041284", "K233477", "K010183", "K241095", "K991322", "K060983", "K991395", "K991345", "K032877", "K030490", "K011481", "K022002", "K081115", "K200680", "K001967", "K023222", "K233764", "K160142", "K991378", "K034063", "K033462", "K053551", "K022295", "K202862", "K022332", "K053552", "K121128", "K092963", "K003734", "K991348", "K120136", "K100367", "K003278", "K173731", "K971809", "K232125", "K082363", "K234023", "K143724", "K232942", "K033101", "K072609", "K242089", "K011606", "K193522", "K180073", "K043116", "K170257", "K112083", "K153478", "K153267", "K072607", "K000937", "K053646", "K030850", "K011607", "K000621", "K032887", "K991341", "K042495", "K003163", "K171224", "K092578", 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"K991330", "K032155", "K021896" ], "registration_number": [ "3005580113", "3030681110", "3008876063", "2031824", "3003766921", "3007738736", "3030390242", "2022379", "3018010054", "3036495174", "1221433", "3003995932", "3021166069", "3014295858", "3004882774", "3036725842", "3014755376", "3025773437", "3004048494", "3033813683", "1222779", "3003272500", "3016126174", "3015140190", "3012853704", "9616005", "1216677", "3003274090", "3010413864", "3007800906", "3017896194" ], "fei_number": [ "3005580113", "3030681110", "3008876063", "3003766921", "3007738736", "3004848623", "3030390242", "2022379", "3018010054", "3036495174", "1221433", "3003995932", "3021166069", "3014295858", "3004882774", "3036725842", "3014755376", "3025773437", "3004048494", "3033813683", "3003272500", "3016126174", "3015140190", "3012853704", "1216677", "1000120774", "3003274090", "3010413864", "3002757762", "3007800906", "3017896194" ], "device_name": "Media, Reproductive", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.6180", "device_class": "2" } } ] }