{
  "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": "4 lots, 360 units ( multiple units per lot)",
      "code_info": "Code 900-2829, 4 lots  140111331  140211831  140312145  140412671",
      "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 BASIC  CODE 900-2829  CONTENTS:\t  (2) TOWELS ABSORBENT 15\" X 20\"  (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE  (1) BAG SUTURE FLORAL  (1) DRAPE T LAPAROT 102\" X 78\" X 121\" STD SMS  (1) COVER TABLE REINFORCED 50\" X 90\"  (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill  (1) TIME OUT BEACON NON WOVEN  (1) COUNTER NDUBLADE 20C FOAM/MAG  (1) SKIN MARKER INK W/8 LABEUTIME OUT/RULER  (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP AAMI LEVEL Ill  Product Usage:  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-2506-2014",
      "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"
    }
  ]
}