{
  "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": "26 lots; 1412 units (multiple units per lot)",
      "code_info": "Product code 900-576,  26 lots:  109020368  109030605  109040844  109051043  109061293  109071535  109081864  109092110  109102391  112030885  112041338  112051871  112062293  112072806  112114577  112125102  113025987  113036372  113078334  113088940  113099442  113109857  131210829  140111239  140211732  140211941",
      "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": "LAPAROSCOPY CHOLECYSTECTOMY PACK -    (1) SHEET LAPAROS/ABDOMINAL UF   (1) MAYO STAND COVER REINFORCED UF  (1) BLADE SURGICAL #11 STAINLESS STEEL   (1) DRAPE SHEET 41 \" X 58\" SMS UF  (10) GAUZE SPONGE 4\" X 4\" 16PL Y XRD UF   (1) TUBE SUCTION CONNEC. 3/16\" x 12' UF  (3) TOWEL ABSORBENT 15\" X 20\" UF   (1) GOWN IMPER. EXTRA REINFORCED LGE TIWRAP  (1) TABLE COVER REINFORCED 50\" X 90\" UF   (2) GOWN LARGE SMS IMPERV. REINFORCED    (4) DRAPE UTILITY WITH TAPE UF    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-2333-2014",
      "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"
    }
  ]
}