{
  "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": "22 lots; 312 units (multiple units per lot)",
      "code_info": "Product code 900-1936, 22  lots:  110082088  110082207  110102439  110112627  110112928  111010082  111030630  111041100  111051372  111061520  111071785  111113056  111123422  112010103  112041214  112062469  112083415  113109769  131210637  140111090  140312098  140412891",
      "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": "UNIVERSAL PACK -   (1) UTILITY BOWL 16oz.  (1) NEEDLE SPINAL ANEST. 22G X 31!2  (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF  (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF  (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF  (1) NEEDLE HYPODERMIC 20G X 1 1!2  (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII  (1) SPLIT SHEET WITH ADHESIVE 108\" X 77\" SMS STD LIF  (1) DRAPE % ECONOMY 53\" X 77\" UF  (2) TOWEL ABSORBENT 15\" X 20\" UF  (4) DRAPE UTILITY WITH TAPE LIF  (1 0) GAUZE SPONGES 4\" X 4\" 12PL Y  (4) TOWELS CLOTH HUCK BLUE  (1) TABLE COVER REINFORCED 50\" X 90\" UF  (1) SCALPEL WITH HANDLE #11  (3) PK. CLOSURE SKIN W' X 4\" STERI STRIP UF  (1) SKIN MARKER WITH RULER  (1) DENTURE CUP 8oz WITH LID  (1) NEEDLE HYPODERMIC 25 X 1 1!2  (1) STOCKINETTE IMPERVIOUS 14\" X 48\"  (2) TIP ABSORB. APPLICATOR STICK SPONGE  (1) TRAY ORGANIZER FULL DEEP  (1) TRA 2/COMPARTMENT  (1) RULER L/F    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-2421-2014",
      "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"
    }
  ]
}