{
  "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": "51 lots; 5574 units (multiple units per lot)",
      "code_info": "Product code 900-645,  51 lots:  109030612  109030699  109051050  109051212  110061464  110071705  110081981  110082075  110092405  110112816  110122898  111010147  111020295  111030648  111041071  111051300  111061559  111071831  111092556  111102774  111112951  111112964  111123280  112010194  112010255  112030736  112052003  112083214  112093731  112104256  112114396  112125106  112125305  113015456  113025965  113036376  113047028  113057498  113078339  113078575  113099294  113099575  131110079  131110411  131110588  140111243  140211676  140211878  140412472  140412889  140513351",
      "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": "0.B. PACK -  -  (1) TABLE COVER 44\" x 90\"  (1) UNDERBUTTOCK DRAPE WITH POUCH  (2) LEGGINS WITH 7\" CUFF 30\" x 42\"  (1) GOWN IMPERVIOUS REINFORCED LARGE SMS  (3) TOWELS ABSORBENT 15\" x 20\"  (1) PAD OBSTETRICAL X-LARGE  (1) VAGINAL SPONGE XRD  (10) GAUZE SPONGES 4\" X 4\" 12PLY XRD  (1) CORD UMBILICAL CLAMP  (1) BABY BLANKET PRINTED  (2) EAR/ULCER SYRINGE 2oz  (1) SET UP COVER CLEAR POLY  (1) BASIN WASH 7QT.  (1) ABDOMINAL DRAPE WITH TAPE LIF  (2) KELLY FORCEP STRAIGHT 5 %  (1) MAYO SCISSOR STRAIGHT 6%  (1) BABY BEANNIES    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-2342-2014",
      "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"
    }
  ]
}