{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Fajardo",
      "address_1": "Calle Igualdad Final #7",
      "reason_for_recall": "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",
      "address_2": "",
      "product_quantity": "4 lots, 114 units, multiple units per lot",
      "code_info": "900-2616, 4 lots:  112083077  113109907  131110339  140312139",
      "center_classification_date": "20140829",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the state of  Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.",
      "state": "PR",
      "product_description": "Shoulder Pack, Code 900-2616, contains:  (2) TUBE SUCTION CONNECT Y.\"X12' UF   (1) SYRINGE 20CC W/0 NDL UL UF  (2) DRAPE VIDEO CAMERA UF   (1) COVER MAYO STAND REINF. UF  (5) SPONGE LAP. PRE-WASH XRD UF   (1) DRAPE U 60\" X 70\" WIT APE UF  (1 0) GAUZE SPONGE 4\" X 4\" 16PL Y XRD UF   (1) DRAPE BEACH CHAIR SHOULDER UF  (1) CO BAN WRAP 4\"X5 YRD LATEX   (1) GOWN IMP. XTRA REINF. X-LGE UF  (1) TUR Y SET 81\" 2.1M REG. CLAM   (1) GOWN IMP. POL YREINF XLGE T/WRAP UF  (1) TABLE COVER REINF. 50\" X 90\" UF    Product Usage:  EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.",
      "report_date": "20140910",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Customed, Inc",
      "recall_number": "Z-2481-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68536",
      "termination_date": "20170814",
      "more_code_info": "",
      "recall_initiation_date": "20140520",
      "postal_code": "00738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}