{
  "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, 402 units ( multiple units per lot)",
      "code_info": "Code 900-2830, 3 lots  140111332  140211832  140412672",
      "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": "ORTHOPEDIC PACK BASIC  CODE 900-2830.  CONTENTS:\t  (3)  TOWELS ABSORBENT 15\" X 20\"  (1)  COVER MAYO STAND REINFORCED  (1)  U-DRAPE 60\" X 70\" WITH TAPE SPLIT 6 X 21 SPLIT (1)  DRAPE% ECONOMY 53\" X 77\"  (4)  DRAPE UTILITY  WITH TAPE (1)  BAG SUTURE FLORAL  (1)  SHEET SPLITW/ADHES 108\"  X 77\" STD SMS (1)  COVER TABLE REINFORCED 50\" X 90\"  (1)  STOCKINETTE IMPERVIOUS 14\" X 48\" (1)  TIME OUT BEACON NON WOVEN  (1)  GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill  (1) POLISHER CAUTERY TIP  (1)  SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1)  COUNTER  NDLIBLADE 20C FOAM/MAG  (1)  PENCIL CAUTERY ROCKER SWITCH WITH  HOLSTER  (1)  GOWN IMPERVIOUS EXTRA REINFORCED LGE T/WRAP  AAMI LEVEL Il  (1)  BAG GLASSINE  PLAIN  (1)  ELECTRODE DUAL DEPRES    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-2507-2014",
      "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"
    }
  ]
}