{
  "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": "35 lots; 11472 units (multiple units per lot)",
      "code_info": "Product code 900-404,  35 lots:  102030840  111030924  111041044  111051296  111061668  111123243  112010164  112020524  112041317  112041373  112041448  112062487  112083429  112114599  112125087  112125314  113025961  113036355  113036763  113047220  113057480  113057846  113068046  113078323  113078574  113089071  113099290  113099572  131110410  131110587  131210971  140111452  140211742  140412837  140513247",
      "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": "MAJOR LAP PACK -  (1) TABLE COVER REINF. 50\" X 90\" 10) GUZE SPONGE 4\" X 4\" 16PLY XRD  (1) DRAPE T LAPAROT 102\" X 78\" X 121\" SMS (1) UTILITY BOWL 32oz  (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER  (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE  (2) LIGHT SHIELD (1) MAYO STAND COVER REINFORCED  (4) ABSORBENT TOWELS 15\" X 20\" (2) DRAPE SHEET 41\" X 58\" SMS  (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (2) GOWN XL SMS IMPERV. REINFORCED  (1) SUTURE BAG FLORAL (1) TIME OUT BEACON NON WOVEN  (5) LAP SPONGE PREWASH 18\" X 18\" XRD (1) SKIN MARKER W/8/LABEL/TIME OUT/RULER    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-2321-2014",
      "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"
    }
  ]
}