{
  "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": "2 lots, 93 units, multiple packed units per lot",
      "code_info": "Product code 900-2516, 2 lots:  131110250  131210792",
      "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, 900-2516, pack contains:  ( I) TABLE COVER44\" X 90\"   ( I) CAUTERY PENCIL PUSH BOTTOM  (4) TOWELS ABSORBENT 15\" X 20\" L/F   ( I) BULB SYRINGE 60cc LIF  (4) DRAPE UTILITY WIT APE LIF   (I) SKIN MARKER W/RULER  ( I) SUTURE BAG FLORAL LIF   ( I) Y ANKAUER SUCTION TUBE W/0 VENT LIF  (2) COUNTER NDL /BLADE IOc MAG/CLEAR   ( I) GOWN XL SMS IMPERV. REINFORCED LIF  (5) LAP SPONGE PREWASH 18\" X 18\" XRD LIF   ( I) GOWN SURG REINFORCED. LGE T/WRAP LIF  ( I) TUBE SUCTION CONNECT W' X 12' LIF   (2) LITE GLOVE LIF  ( 10) GAUZE SPONGE4\" X 4\" 16PLY XRD LIF   (2) DRAPE SHEET 41\" X 58\" SMS LIF  ( I) CAUTERY TIP POLISHER LIF   ( I) MERLING SKIN PREP APPLIC. 39ML LIF  ( I) UTILITY BOWL PINT 16oz LIF   ( I) SKIN STAPLE 35 WIDE LIF  ( I) UTILITY BOWL QUART 32oz LIF  ( I) BLADE SURGICAL II CARBON STEEL  ( I) TRAY MAYO SMALL   ( I) BLADE SURGICAL 20 CARBON STEEL  ( I) MAYO STAND COVER REINFORCED LIF   ( I) DRAPE LAPAROTOMY 100\" X 72\" X 124\" W/POUCH    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-2476-2014",
      "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"
    }
  ]
}