{
  "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": "2 lots; 40 units (multiple units per lot)",
      "code_info": "Product code 900-576A,  2 lots:  140312024  140513373",
      "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 SURGICAL PACK -  -      (1) DRAPE LAPAROS/ABDOMINAL UF   (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP  (1) BLADE SURGICAL #11 STAINLESS STEEL   (1) TIME OUT BEACON NON WOVEN UF  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD UF   (1) GOWN XLARGE SMS IMPERV. REINFORCED  (3) TOWEL ABSORBENT 15\" X 20\" UF   (1) TUBBING INSUFFLATION SET WITHOUT RING  (1) MAYO STAND COVER REINFORCED UF   (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG UF  (1) TABLE COVER REINFORCED 50\" X 90\" UF   (1) SKIN MARKER INKW/8LABEUTIME OUT/RULER  (1) DRAPE SHEET 41 \" X 58\" SMS UF   (1) BAG SUTURE FLORAL  (4) DRAPE UTILITY UF   (1) TUR CYSTO IRRIGATION SET 79\" SINGLE UF  (1) TUBE SUCTION CONNECT. 3/16 \" x 12' 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-2334-2014",
      "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"
    }
  ]
}