{
  "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": "38 lots; 3066 units (multiple units per lot)",
      "code_info": "Product code 900-742,  38 lots:  110092282  110112680  110122944  111010190  111020296  111041070  111061687  111071387  111071969  111082110  111092402  111102779  111113140  111123292  112010203  112020493  112030743  112041353  112052012  112062507  112093642  112104103  112114589  112125112  113015460  113025776  113025985  113036767  113067963  113068180  113088888  113099453  113109871  131110275  131210841  140111250  140211737  140311948",
      "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": "CARPALTUNNELLARGE -    (1) TABLE COVER 50\" X 90\" REINFORCED LIF  (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF  (1) UTILITY BOWL 32oz LIF  (2) DRAPE SHEET 41 \" X 58\" SMS  (1) BANDAGE GAUZE 4\" STRETCH  (1) NEEDLE HYPODERMIC 25G X 5/8\"  (1) STOCKINETTE 6\" X 48\" LIF  (2) CLOTH HUCK TOWEL BLUE  (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP  (1) GOWN SURGICAL REINF XL TOWEL/WRAP  (1) NEEDLE HYPODERMIC 18G X 1 %\"  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD L.F  (1) UTILITY BOWL 16oz LIF  (1) ABSORBENT TOWELS 15\" X 20\" LIF  (1) CAST PADDING  (2) SURGICAL BLADE #15 STAINLESS STEEL  (4) DRAPE UTILITY WITH TAPE L/F  (1) SHEET EXTREMITY ABS. 125\" x 85\" SMS     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-2348-2014",
      "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"
    }
  ]
}