{ "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": "216319", "product_res_number": "Z-0184-2026", "event_date_initiated": "2025-09-04", "event_date_posted": "2025-10-16", "recall_status": "Open, Classified", "res_event_number": "97659", "product_code": "OJH", "product_description": "Medical convenience kits \n\nItem Number/Description\nANSH14AF\tSHOULDER PACK - 205962\nEVAH76H\tANTERIOR HIP PACK\nFDSA15M\tSHOULDER ARTHROSCOPY\nGRTS90G\tTOTAL SHPULDER PACK \nHGHI26G\tHIP PINNING PACK\nHJTO25C\tTOTAL HIP ACCESSORY PACK\nHNEX60L\tEXTREMITY PACK\nIAHD53C\tHAND PACK\nIASH65A\tSHOULDER PACK\nIHUE40AI\tUPPER EXTREMITY PK| STRL F G\nILTJ47AA\tTOTAL JOINT PACK\nLMHP14Z\tORIF HIP, ST LUKES METHODIS\nLMSN44AE\tSPINAL PACK\nMHHP25H\tHAND PACK - 206002\nMHTH90AJ\tTOTAL HIP PACK - 206016\nMWAH32P\tANTERIOR HIP PACK\nMWTK13AH\tTOTAL KNEE\nPLOR89H\tORTHO MINOR PACK\nRCUE81B\tUPPER EXTREMITY RCH 0247031\nTSTH54D\tTOTAL HIP TRAY\nUDEX85Y\tDSC EXTREMITY - 206050\nUDHD69U\tHAND PACK - 206055\nUDKN68AH\tCUSTOM KNEE - 206061\nUIHN18AW\tACS HAND PACK (PS 020640)\nUIHN18AX\tACS HAND PACK (PS 020640)\nUIKN28AR\tASC KNEE PACK (PS 020641)\nUISO44I\tSFCH SMALL ORTHO PACK (PS 143213)", "code_info": "AMEX26AA\nUDI-DI 191072207340\nlot 7958811\nbag serial number N/A;\n\nANSH14AF\nUDI-DI 00191072214461\nlot 8137411\nbag serial numbers\n68274173\n68274192;\n\nEVAH76H\nUDI-DI 191072221858\nlot 8367611\nbag serial number\n68566760;\n\nFDSA15M\nUDI-DI 191072185396\nlot 8076011\nbag serial number\n68117299;\n\nGRTS90G\nUDI-DI 191072208262\nlot 8532411\nbag serial number\nN/A;\n\nHGHI26G\nUDI-DI 191072212559\nlot 8161611\nbag serial number\nN/A;\n\nHJTO25C\nUDI-DI 191072105684\nlot 8071011\nbag serial numbers\n17505916\n17506159;\n\nHNEX60L\n191072193643\nlot 8487711\nbag serial number\n68641794;\n\nIAHD53C\nUDI-DI 191072232564\nlot 8128911\nbag serial number\n47395092;\n\nIASH65A\nUDI-DI 191072224477\nlot 8058211\nbag serial number\nN/A;\n\nIHUE40AI\nUDI-DI 191072234100\nlot 8181611\nbag serial number\nN/A;\n\nILTJ47AA\nUDI-DI 197012208279\nlot 8518611\nbag serial number\n68865822;\n\nLMHP14Z\nUDI-DI 191072202932\nlot 8136111\nbag serial number\nN/A;\n\nLMSN44AE\nUDI-DI 191072236265\nlot 8450311\nbag serial number\nN/A;\n\nMHHP25H\nUDI-DI 191072214983\nlot 7986811\nbag serial number\nN/A;\n\nMHTH90AJ\nUDI-DI 191072216120\nlot 7982511\nbag serial number\nN/A;\n\nMWAH32P\nUDI-DI 191072208538\nlot 7974911\nbag serial number\nN/A;\n\nMWTK13AH\nUDI-DI 191072225344\nlot 8040111\nbag serial number\nN/A;\n\nPLOR89H\nUDI-DI 191072225740\nlot 8172511\nbag serial numbers\n47394380\n47498107;\n\nRCUE81B\nUDI-DI 191072226266\nlot 8065011\nbag serial number\n68137959;\n\nTSTH54D\nUDI-DI 191072229878\nlot 8411811\nbag serial number\n68666214;\n\nUDEX85Y\nUDI-DI 191072216267\nlot 8047611\nbag serial number N/A;\n\nUDHD69U\nUDI-DI 191072216298\nlot 7991811\nbag serial number \n17402072;\n\nUDKN68AH\nUDI-DI 191072226013\nlot 8046511\nbag serial number\n68045970;\n\nUIHN18AW\nUDI-DI 191072228956\nlot 8025311\nbag serial number\n68153870;\n\nUIHN18AX\nUDI-DI 191072234049\nlot 8192211\nbag serial number\n68195746;\n\nUIKN28AR\nUDI-DI 191072228970\nlot 8049011\nbag serial number\n68135550;\n\nUISO44I\nUDI-DI 191072205407\nlot 8027311\nbag serial number\n68153822\n\n\n* If bag serial number is listed as \"N/A\", then whole lot is affected", "firm_fei_number": "3007069947", "recalling_firm": "American Contract Systems Inc.", "address_1": "1601 Se Gateway Dr Ste 120 1601 Se Gateway Dr", "address_2": "Ste 120", "city": "Grimes", "state": "IA", "postal_code": "50111-5223", "additional_info_contact": "Marlene Jones\n470-280-4277", "reason_for_recall": "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.", "root_cause_description": "Nonconforming Material/Component", "action": "Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers.\n\nConsignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.", "product_quantity": "32,433 total", "distribution_pattern": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.", "openfda": { "device_name": "Orthopedic Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1", "registration_number": [ "3007289408", "1020279", "3005595283", "2029015", "3015131017", "3007663067", "3007329020", "3002807315", "3014554088", "3011430871", "3011187779", "9710629", "3008395366", "3009888344", "1417592", "1643817", "1221053", "8031020", "3006981798", "3009203853", "1030451", "3008111820", "3008864603", "3015543569", "3004111573", "1835444", "3017823294", "3004911384", "1047429", "3014170143", "3014680744", "3045816907", "3008544874", "1423537", "3018077422", "3003477135", "1928237", "1423395", "3010667733", "9616088", "1424263", "3035642068", "1825034", "3013552417", "3017307654", "3008534770", "8044102", "1123137", "1450662", "3005012805", "3015173212", "1061124", "3012120772", "1043534", "1923569", "3004122598", "3045816902", "3010052483" ], "fei_number": [ "1000160458", "3007289408", "3000717925", "3003407235", "3005595283", "1020279", "3002902735", "3015131017", "3001236905", "3007663067", "3007329020", "3002807315", "3014554088", "3011430871", "3011187779", "1643817", "3008395366", "3009888344", "1417592", "1221053", "3006981798", "3009203853", "1030451", "3008111820", "3008864603", "3015543569", "3004111573", "3017823294", "3004911384", "3045816907", "1047429", "3014170143", "3014680744", "3008544874", "3002807830", "3018077422", "3003477135", "3003015552", "1928237", "3010667733", "3035642068", "1825034", "1000512168", "3013552417", "3017307654", "1000123180", "3008534770", "1450662", "3005012805", "3015173212", "3012120772", "1043534", "1923569", "3004122598", "3045816902", "3010052483", "3013299874", "3000717687" ] } } ] }