{
  "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": "19 lots; 1168 units (multiple lots per unit)",
      "code_info": "Product code 900-474, 19  lots:  112030843  112103944  112114393  112114480  112125096  113015452  113036801  113057847  113078330  113088867  113089075  113109844  131110262  131210818  140111232  140211671  140412469  140412888  140513480",
      "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 PACK-  -  (1) DRAPE LAP ABDOMINAL WITH POUCH  (1) CAMARA DRAPE 9\" X 96\" LIF  (5) TOWELS ABSORBENT 15\" X 20\"  (1) MAYO STAND COVER REINFORCED  (1) TABLE COVER REINFORCED 50\" X 90\"  (4) DRAPE UTILITY WITH TAPE  (3) DRAPE SHEET 41\" X 58\" SMS  (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR  (5) LAP SPONGE PREWASH 18\" X 18\" XRD  (1) GOWN LGE SMS IMPERVIOUS REINFORCED  (2) GOWN X-LARGE SMS IMPERV. REINFORCED  (2) MEDICINE CUP 2oz.  (1) NEEDLE HYPODERMIC 18G X 1% ST.  ( 1) BLADE SURG. # 15 CARBON STEEL  (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK  (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR  (1) DRESSING TEGADERM 4\" X 4%\"  (1) SOLUTION SURGICAL DURAPREP 6mL  (1) TRAY MAYO SMALL  (1) TUBE SUCTION CONNECT. %\"X 12'  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD  (1) NEEDLE ECLIPSE 22 X 1%  (1) TIME OUT BEACON NON WOVEN ST  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-2327-2014",
      "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"
    }
  ]
}