{
  "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": "7 lots; 128 units (multiple units per lot)",
      "code_info": "Product code 900-1803, 7  lots:  112114857  112125169  113026230  113036759  140312276  140412556  140513115",
      "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 PREMIUM PACK -   (1) TABLE COVER REINFORCED 50\" x 90\" UF  (4) TOWEL ABSORBENT 15\" x 20\" UF  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD UF  (1) DRAPE LASER CAMERA W/EL UF  (1) TROCAR ENDO.XCEL DILATING TIP (KSLT)  (1) APPLIER CLIP 5MM  (3) GOWN XLGE SMS IMPERV. REINFORCED  (1) BLADE SURGICAL #11 S/STEEL  (1) NEEDLE PNEUMO INSUFLAT. 150MM UL UF  (1) MAYO STAND COVER REINFORCED UF  (1) DRAPE LAPAROSCOPY ABDOM. W/POUCH  (4) DRAPE UTILITY WITH TAPE UF  (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR U/F  (1) TROCAR DILATING XCEL 5MM x 100 (D5LT)  (1) TROCAR ENDO.XCEL DILATING TIP 11MM  (1) SUTURE BAG FLORAL UF  (1) CLOSURE SKIN W' X 4\" STERI STRIP LF    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-2413-2014",
      "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"
    }
  ]
}