{
  "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": "8 lots, 273 units (multiple units per lot)",
      "code_info": "Code 900-2918, 8 lots  113047023  113057703  113068037  113078429  113078733  113109799  140312147  140613795",
      "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": "TLIF PACK   SURGICAL CENTER, CODE 900-2918.  CONTENTS:\t  (2)    SOLUTION SURGICAL DURAPREP 26ML  UF   (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF   (4)    GOWN SOFT SMS STD XL SET IN SLEEVE UF   (4)   TOWELS ABSORBEN 15\" X 20\" LIF  (1)   TABLE COVER REINFORCED 50\" X 90\" LIF   (1) MAYO STAND COVER REINFORCED LIF   (4) DRAPE% 60\" X 76\" REINFORCED L/F  (1) DRAPE CHEST 100\" X 142\" X 72\"  LIF  (1) FLUORO COVER 30\" X 30\" WITH RUBBBAND LIF   (2) LITE GLOVE LIF  (2)    TUBE SUCTION CONNECT. Y.\" X 12' UF   (12)  TOWELS CLOTH HUCK  BLUE LIF  (1) UTILITY BOWL QUART 32oz  (10)  GAUZE SPONGE  4\" X 4\" 16PLY XRD UF  (5) LAP SPONGE PREWASH 18\" X 18\" XRD LIF  (1)    CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF   (1)    STERI STRIP DRAPE LARGE 17\" X 23\" LIF  (1) SKIN MARKER WITH RULER UF  (9) LABELS FOR SKIN MARKERS 1.25 X Y2   (1) RULER  (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG  L/F  (2)    SYRINGE 20cc WITHOUT  NEEDLE LUER LOCK LIF   (2)    SYRINGE 10cc WITHOUT  NEEDLE  LUER LOCK LIF   (1)    BULB SYRINGE 60cc LIF  (4) NEEDLE HYPODERMIC 18G X 1Y2 UF  (1) NEEDLE HYPODERMIC 22G X 1Y2 LIF  (2) SYRINGE 3cc WITHOUT NEEDLE  LUER LOCK UF   (1) NEEDLE SPINAL 18G X 6\" LONG LENGTH LIF  (1) BLADE SURGICAL # 10 CARBON STEEL   (1) BLADE SURGICAL # 15 CARBON STEEL  (1) TIME OUT BEACON NON  WOVEN UF   (2) DRESSING TEGADERM 4\" X 4% \"UF   (2) MEDICINE  CUP 2oz  (1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23\" X 23\" LIF  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-2512-2014",
      "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"
    }
  ]
}