{
  "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": "16 lots; 327 units (multiple units per lot)",
      "code_info": "Product code 900-1985, 16 lots:  112030698  112041408  112083418  112093632  112114384  112114490  112125051  113025843  113026052  113026108  113036788  113057730  113078294  113088775  113099406  140111191",
      "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": "SHOULDER PACK- CUSTOMED-    (1) TABLE COVER REINFORCED 50\" x 90\" LIF  (2) MAYO STAND COVER REINFORCED L/F  (1) U-DRAPE 60\" X 70\" WITH TAPE SPLIT  (4) TOWELS ABSORBENT 15\" X 20\" LIF  (4) DRAPE UTILITY WITH TAPE LIF  (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE  (1) SHEET DRAPE 70\" X 100\" SMS LIF  (1) CUP SPECIMEN WITH CAP 4oz  (1) TUBE SUCTION CONNECT. Y.\" X 12' LIF  (1) SKIN MARKER WITH RULER  (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF  (1) BAG SUTURE FLORAL LIF  (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF  (1) NEEDLE HYPODERMIC 21G X 1% LIF  (1) BLADE SURGICAL #11 CARBON STEEL  (1) BLADE SURGICAL #15 CARBON STEEL  (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF  (1) NEEDLE SPINAL ANESTH. 18G X 3% LIF  (1) STOCKINETIE IMPERVIOUS 14\" X 48\" LIF  (1) DRAPE BEACH CHAIR SHOULDER ARTHROSC.  (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP  (2) GAUZE SPONGE 4\" X 4\" 16PL Y XRD 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-2426-2014",
      "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"
    }
  ]
}