{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Grimes",
      "state": "IA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97659",
      "recalling_firm": "American Contract Systems Inc.",
      "address_1": "1601 Se Gateway Dr Ste 120",
      "address_2": "",
      "postal_code": "50111-5223",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.",
      "recall_number": "Z-0184-2026",
      "product_description": "Medical convenience kits     Item Number/Description  ANSH14AF\tSHOULDER PACK - 205962  EVAH76H\tANTERIOR HIP PACK  FDSA15M\tSHOULDER ARTHROSCOPY  GRTS90G\tTOTAL SHPULDER PACK   HGHI26G\tHIP PINNING PACK  HJTO25C\tTOTAL HIP ACCESSORY PACK  HNEX60L\tEXTREMITY PACK  IAHD53C\tHAND PACK  IASH65A\tSHOULDER PACK  IHUE40AI\tUPPER EXTREMITY PK| STRL F G  ILTJ47AA\tTOTAL JOINT PACK  LMHP14Z\tORIF HIP, ST LUKES METHODIS  LMSN44AE\tSPINAL PACK  MHHP25H\tHAND PACK - 206002  MHTH90AJ\tTOTAL HIP PACK - 206016  MWAH32P\tANTERIOR HIP PACK  MWTK13AH\tTOTAL KNEE  PLOR89H\tORTHO MINOR PACK  RCUE81B\tUPPER EXTREMITY RCH 0247031  TSTH54D\tTOTAL HIP TRAY  UDEX85Y\tDSC EXTREMITY - 206050  UDHD69U\tHAND PACK - 206055  UDKN68AH\tCUSTOM KNEE - 206061  UIHN18AW\tACS HAND PACK (PS 020640)  UIHN18AX\tACS HAND PACK (PS 020640)  UIKN28AR\tASC KNEE PACK (PS 020641)  UISO44I\tSFCH SMALL ORTHO PACK (PS 143213)",
      "product_quantity": "32,433 total",
      "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.",
      "recall_initiation_date": "20250904",
      "center_classification_date": "20251016",
      "report_date": "20251022",
      "code_info": "AMEX26AA UDI-DI 191072207340 lot 7958811 bag serial number N/A;  ANSH14AF UDI-DI 00191072214461 lot 8137411 bag serial numbers 68274173 68274192;  EVAH76H UDI-DI 191072221858 lot 8367611 bag serial number 68566760;  FDSA15M UDI-DI 191072185396 lot 8076011 bag serial number 68117299;  GRTS90G UDI-DI 191072208262 lot 8532411 bag serial number N/A;  HGHI26G UDI-DI 191072212559 lot 8161611 bag serial number N/A;  HJTO25C UDI-DI 191072105684 lot 8071011 bag serial numbers 17505916 17506159;  HNEX60L 191072193643 lot 8487711 bag serial number 68641794;  IAHD53C UDI-DI 191072232564 lot 8128911 bag serial number 47395092;  IASH65A UDI-DI 191072224477 lot 8058211 bag serial number N/A;  IHUE40AI UDI-DI 191072234100 lot 8181611 bag serial number N/A;  ILTJ47AA UDI-DI 197012208279 lot 8518611 bag serial number 68865822;  LMHP14Z UDI-DI 191072202932 lot 8136111 bag serial number N/A;  LMSN44AE UDI-DI 191072236265 lot 8450311 bag serial number N/A;  MHHP25H UDI-DI 191072214983 lot 7986811 bag serial number N/A;  MHTH90AJ UDI-DI 191072216120 lot 7982511 bag serial number N/A;  MWAH32P UDI-DI 191072208538 lot 7974911 bag serial number N/A;  MWTK13AH UDI-DI 191072225344 lot 8040111 bag serial number N/A;  PLOR89H UDI-DI 191072225740 lot 8172511 bag serial numbers 47394380 47498107;  RCUE81B UDI-DI 191072226266 lot 8065011 bag serial number 68137959;  TSTH54D UDI-DI 191072229878 lot 8411811 bag serial number 68666214;  UDEX85Y UDI-DI 191072216267 lot 8047611 bag serial number N/A;  UDHD69U UDI-DI 191072216298 lot 7991811 bag serial number  17402072;  UDKN68AH UDI-DI 191072226013 lot 8046511 bag serial number 68045970;  UIHN18AW UDI-DI 191072228956 lot 8025311 bag serial number 68153870;  UIHN18AX UDI-DI 191072234049 lot 8192211 bag serial number 68195746;  UIKN28AR UDI-DI 191072228970 lot 8049011 bag serial number 68135550;  UISO44I UDI-DI 191072205407 lot 8027311 bag serial number 68153822   * If bag serial number is listed as \"N/A\", then whole lot is affected",
      "more_code_info": ""
    }
  ]
}