{
  "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": "3 lots; 1941 units (multiple units per lot)",
      "code_info": "Product code 900-281A, 3 lots:  140312027  140412669  140412796",
      "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": "LAPAROTOMY PACK - (I) UTILITY BOWL 16oz   ( I) ELECTRODE DUAL DEPRES./GROUNDPAD  (I) UTILITY BOWL 32oz   ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill  (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR  ( I) DRAPE LAPAROT ABDOM WITH POUCH  (2) TOWELS ABSORBENT 15\" x 20\"   ( I) TIME OUT BEACON NON WOVEN  (4) DRAPE UTILITY (I) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER  (I) MAYO STAND COVER REINFORCED   ( I) SUTURE BAG FLORAL  (I) TABLE COVER REINFORCED 50\" X 90\"   ( I) GOWN IMP EXTRA REINF LGE TOWEUWRAP  (2) DRAPE SHEET 42\" X 55\" SMS   (I) CAUTERY TIP POLISHER  (I) CAUTERY PENCIL ROCKER SWITCH   ( I) BAG GLASSINE  (I) SURGICAL BLADE# 10 STAINLESS STEEL    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-2316-2014",
      "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"
    }
  ]
}