{
  "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": "Product code 900-742A,  4 lots:  140312026  140412702  140513380  140513481",
      "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": "CARPAL TUNNEL SURGICAL LARGE PACK   (1) COVER TABLE 44\" X 90\" LIF  (1) NEEDLE HYPODERMIC 18G X 1 % LIF  (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF  (1) BOWL UTILITY QUART 32oz.  (2) SHEET DRAPE 41\" X 58\" SMS LIF  (2) TOWELS ABSORBENT 15\" X 20\" LIF  (1) BANDAGE GAUZE STRETCH 4\"  (1) NEEDLE HYPODERMIC 25G X 5/8  (2) BLADE SURGICAL #15 STAINLESS STEEL  (2) TOWEL CLOTH HUCK BLUE LIF  (1) PADDING CAST COTTON ROLL 2\" X 4yds  (1) STOCKINETTE 6\" X 48\" L/F  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (4) DRAPE UTILITY LIF  (1) GOWN SURG. FABRIC REINFORCED X-LARGE AAMI Ill LIF  (1) TIME OUT BEACON NON WOVEN  (1) HAND DRAPE ORTHOARTSO 76\" X 150\"  (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F  (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER  (1) BAG SUTURE FLORAL L/F  (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGEL TOWEL/WRAP L/F    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-2349-2014",
      "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"
    }
  ]
}