{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198174", "product_res_number": "Z-1314-2023", "event_date_initiated": "2023-01-16", "event_date_posted": "2023-04-01", "recall_status": "Open, Classified", "res_event_number": "91557", "product_code": "MQL", "k_numbers": [ "K011938" ], "product_description": "Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305", "code_info": "UDI-Di Code: 08937270029305TH\nCatalog Number / Lot Numbers:\n9305-100ml / 0000011351,\n9305-500ml / 0000011367,\n9305-100ml / 0000015999,\n9305-500ml / 0000016001", "firm_fei_number": "2022379", "recalling_firm": "Fujifilm Irvine Scientific, Inc.", "address_1": "2511 Daimler St", "city": "Santa Ana", "state": "CA", "postal_code": "92705-5533", "additional_info_contact": "Melissa Gomez\n949-261-7800 Ext. 457", "reason_for_recall": "Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.", "root_cause_description": "Nonconforming Material/Component", "action": "On 01/16/2023, the firm emailed an \"URGENT: MEDICAL DEVICE RECALL\" Letter to customers informing them that, the firm has received complaints of reduced blastocyst development, including complete degradation in some cases, during culture of human embryos. Additionally, some clinics performed Human Sperm Survival Assay (HSSA), as part of incoming confirmatory Quality Control testing, and reported low sperm motility.\n\nCustomers are instructed to:\n1. Immediately stop using the product;\n2. Quarantine any remaining product in inventory;\n3. Return or destroy the product;\n4. Complete and return the enclosed MEDICAL DEVICE RETURN RESPONSE FORM; and\n5. Email the completed MEDICAL DEVICE RETURN RESPONSE FORM to fisira@fujifilm.com by January 23, 2023.\n\nFor questions, contact: Customer Service Manager, Medical Business:\n- Toll free in the US: 1.800.577.6097\n- Phone: 1.949.261.7800 x457\n- Email: Melissa Gomez, fisitmrequest@fujifilm.com", "product_quantity": "15,131 bottles", "distribution_pattern": "U.S.: AZ, AR, CA, CT, DC, FL, HI, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WI and WV.\n\nO.U.S.: India, Israel, Japan, Malaysia, Mexico, South Korea, South Africa, Thailand, Vietnam, Brazil, Bosnia, Argentina, Netherlands, and United Kingdom", "openfda": { "k_number": [ "K251637", "K223265", "K011462", "K133568", "K034063", "K072609", "K101003", "K153267", "K260248", "K171748", "K000938", "K070689", "K991334", "K152440", "K991332", "K042495", "K202862", "K030490", "K081115", "K030441", "K100367", "K190152", "K983579", "K864524", "K991339", "K081117", "K092107", "K991472", "K023222", "K023106", "K180073", "K991333", "K000621", "K033462", "K061145", "K152717", "K991342", "K021890", "K000939", "K121572", "K160863", "K023353", "K173624", "K010183", "K011607", "K040530", "K022247", "K002383", "K000937", "K022547", "K133387", "K080172", "K991322", "K043116", "K140317", "K183486", "K003448", "K161261", "K002630", "K030850", "K234023", "K113786", "K242968", "K011481", "K152932", "K022295", "K013518", "K022335", "K031228", "K003156", "K001967", "K032154", "K991419", "K160864", "K000989", "K003163", "K991331", "K002623", "K023033", "K171224", "K991378", "K000627", "K001113", "K991348", "K032877", "K003734", "K072608", "K252672", "K971809", "K991391", "K170498", "K160142", "K092667", "K133707", "K991381", "K021893", "K033101", "K023850", "K991380", "K070135", "K021896", "K190199", "K053494", "K991390", "K011938", "K991279", "K000940", "K192845", "K041284", "K061309", "K000619", "K983584", "K991346", "K000309", "K991470", "K031015", "K092578", "K022334", "K193522", "K991173", "K060699", "K233846", "K032887", "K980814", "K080446", "K172197", "K984172", "K991345", "K200249", "K150950", "K993484", "K991330", "K991393", "K023717", "K151367", "K213293", "K011157", "K212426", "K191063", "K242043", "K170257", "K121128", "K022443", "K991421", "K053646", "K242107", "K022330", "K000623", "K081114", "K000626", "K242640", "K082363", "K092963", "K242561", "K222606", "K011573", "K200408", "K022245", "K991379", "K991420", "K073522", "K991327", "K003278", "K182002", "K021358", "K153478", "K231370", "K190383", "K254261", "K240605", "K023206", "K023655", "K991392", "K024290", "K003751", "K030116", "K032155", "K002385", "K022931", "K152782", "K160006", "K242089", "K991337", "K031304", "K030117", "K081116", "K223117", "K241095", "K173731", "K192503", "K991341", "K112083", "K133912", "K191552", "K142991", "K991343", "K081639", "K022002", "K251305", "K011606", "K022590", "K170602", "K022332", "K983589", "K080473", "K093273", "K193285", "K170681", "K031486", "K232125", "K143498", "K991395", "K212410", "K072607", "K060983", "K983586", "K192644", "K152904", "K232942", "K060168", "K991338", "K162409", "K241833", "K152682", "K241132", "K170560", "K240149", "K233764", "K053551", "K000618", "K002836", "K012123", "K250445", "K991329", "K011346", "K022352", "K991335", "K991022", "K160814", "K240176", "K120136", "K022244", "K220715", "K023403", "K153290", "K200680", "K983588", "K991396", "K991471", "K143724", "K053552", "K983580", "K021894", "K233477", "K061371", "K020490", "K003404", "K991351", "K083509", "K000625" ], "registration_number": [ "3036725842", "3003272500", "3007800906", "3005580113", "1216677", "2031824", "3036495174", "3010413864", "3003766921", "3008876063", "1221433", "3018010054", "3004882774", "3007738736", "3016126174", "3004048494", "1222779", "3015140190", "3014755376", "3033813683", "2022379", "3012853704", "3003995932", "9616005", "3025773437", "3017896194", "3030390242", "3021166069", "3030681110", "3003274090", "3014295858" ], "fei_number": [ "3036725842", "3003272500", "3007800906", "3005580113", "1216677", "3036495174", "3010413864", "3003766921", "3008876063", "1221433", "1000120774", "3018010054", "3004882774", "3007738736", "3016126174", "3004048494", "3015140190", "3014755376", "3004848623", "3033813683", "2022379", "3012853704", "3003995932", "3002757762", "3025773437", "3017896194", "3030390242", "3021166069", "3030681110", "3003274090", "3014295858" ], "device_name": "Media, Reproductive", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.6180", "device_class": "2" } } ] }