{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "159601", "product_res_number": "Z-0552-2018", "event_date_initiated": "2017-11-01", "event_date_created": "2018-02-07", "recall_status": "Terminated", "event_date_terminated": "2020-07-22", "res_event_number": "78444", "product_code": "NOC", "product_description": "ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9", "code_info": "(a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2", "firm_fei_number": "2110898", "recalling_firm": "3M Company - Health Care Business", "address_1": "3m Center 2510 Conway Ave , B# 275-5-W-6 2510 3m center conway ave b# 275-5-w-6", "city": "Saint Paul", "state": "MN", "postal_code": "55144-0001", "additional_info_contact": "651-733-1110", "reason_for_recall": "Mold was found on the non-patient contact\nsurfaces of the product and was identified as\nAspergillus candidus.", "root_cause_description": "Packaging process control", "action": "The firm initiated their recall on 11/01/2017 by letter. The letter requested the consignee cease distribution of the recalled product, isolate it pending return. Distributors were asked to notify their customers including a copy of the 3M recall notice.", "product_quantity": "996 units", "distribution_pattern": "AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN,\nKS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH,\nOR, PA, SC, TN, TX, UT, VA, WI, WV", "openfda": { "registration_number": [ "3006065092", "3015422337", "3026263452", "3009240907", "9615334", "3023316", "3013473968", "3004034546", "3014368824", "3007143190", "3017181414", "3010951382", "1523560", "3007141164", "3008342617", "3010785927", "3021313801", "3043226252", "3002754225", "3009171220", "1064808", "3003781173", "3009512503", "3012034017", "3003781172", "3008258694", "3010699203", "3013527364", "3017633586", "3003418325", "3029961128", "3030017177", "3013226", "3009605026", "3013496867", "3005831263", "3007865243", "3006008854", "3011209824", "3017910381", "3017297225", "3006789548", "3004443928", "3013034812", "1954553", "3011786430", "3006943846", "1036781", "3009119999", "3010952189", "1032347", "9680411", "3033436414", "3024104912", "3005841961", "3008384335", "2183650", "3004905643", "3013684763", "3004179819", "3021275665", "3010951384", "3011529314", "3010123014", "3013856565", "3026310731", "3011497619", "3025430561", "3009068676", "1931876", "3004824601", "3005533873", "3027617478", "3013515242", "3020998987", "1932015", "3011715922", "3007076137", "3015337116", "3013657868", "3045526618", "3045742729", "3012494290", "3007647244", "2110420", "1523574", "3043047582", "3005621808", "3031218453", "2032384", "3004161950", "3009540516", "1721819", "1519375", "3015745029", "3010373263", "9616354", "3012711490", "9616086", "3042251628", "3017264244", "3009303371", "3010872396", "1422443", "9612388", "8022890", "3047515274", "3000151096", "2182318", "3012777736", "3010934856", "3011706862", "3010160370", "3005532347", "3015058854", "3003764610", "3011621895", "3014301546", "3014150341", "3008957229", "3002404380", "3030956456", "3011983031", "3031582440", "3023346034", "3013718153", "3021282544", "3014982318", "3003890514", "3006231901", "3007407648", "3026818268", "3008264111", "3018759542", "3012907824", "3015495690", "3020977243", "3026938250", "3034605486", "3015376545", "1649245", "3011767915", "3033484057", "3009124884", "3015277818", "3005460813", "3001650535", "3031564213", "1528440", "3034602341", "3011556461", "3014273557", "3011657181", "3004755235", "2028810", "1122845", "3011650322", "1218386", "1250045", "3038295725", "3017844600", "3037012186", "1038963", "3012841710", "2080225" ], "fei_number": [ "3006065092", "3015422337", "3026263452", "3009240907", "3023316", "3013473968", "3004034546", "3014368824", "3007143190", "3017181414", "3010951382", "1523560", "3007141164", "3008342617", "3010785927", "3021313801", "3043226252", "3002754225", "3009171220", "3003781173", "3009512503", "3012034017", "3003781172", "3008258694", "3010699203", "3013527364", "3017633586", "3003418325", "3029961128", "3030017177", "3013226", "3009605026", "3013496867", "1000118260", "3007865243", "3003255844", "3005831263", "3006008854", "3011209824", "3017910381", "3017297225", "3006789548", "3004443928", "3013034812", "3011786430", "3006943846", "1000123428", "3009119999", "3010952189", "1000143485", "1032347", "3033436414", "3024104912", "3005841961", "3008384335", "2183650", "3004905643", "3013684763", "3004179819", "3021275665", "3010951384", "3011529314", "3010123014", "3013856565", "3926", "3026310731", "3011497619", "3025430561", "3009068676", "3004824601", "3005533873", "3027617478", "3013515242", "3020998987", "3011715922", "3003273873", "3007076137", "3015337116", "3013657868", "3045526618", "3002705047", "1000111918", "3045742729", "3012494290", "1000135616", "3007647244", "1000117913", "2110420", "1523574", "3043047582", "3005621808", "3031218453", "3003418980", "3004161950", "3009540516", "1721819", "1519375", "3015745029", "3006076154", "3010373263", "3012711490", "3042251628", "3017264244", "3009303371", "3010872396", "1000640265", "3047515274", "3000151096", "2182318", "3012777736", "3010934856", "3011706862", "3010160370", "3000214907", "3005532347", "3015058854", "3003764610", "3011621895", "3014301546", "3014150341", "3008957229", "3002404380", "3030956456", "3011983031", "3031582440", "3023346034", "3013718153", "3021282544", "3014982318", "3003890514", "3006231901", "3003355294", "3007407648", "3026818268", "3008264111", "3018759542", "3012907824", "3015495690", "3020977243", "3026938250", "3034605486", "3015376545", "3011767915", "3033484057", "3009124884", "3015277818", "3005460813", "3001650535", "3031564213", "3034602341", "3011556461", "3014273557", "3011657181", "3004755235", "3011650322", "3008205331", "1218386", "1250045", "3038295725", "3017844600", "1000122527", "3037012186", "1038963", "3012841710", "2080225" ], "device_name": "Splint, Extremity, Non-Inflatable, External, Non-Sterile", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3910", "device_class": "1" } } ] }