{
  "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": "2 lots/ 54 units, multiple units per lot",
      "code_info": "Code 900-2660, 2 lots:  112062218  112093621",
      "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": "Breast Implant Pack, Code 900-2660, contains:  (1) DRAPE  ECONOMY 53 X 77  (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE  (3) TOWELS ABSORBENT 15 X 20  (1) MAYO STAND COVER REINFORCED  (2) TABLE COVER REINFORCED 50 X 90  (1) SUTURE BAG FLORAL  (1) TUBE SUCTION CONNECT Y  (6) TOWEL CLOTH HUCK BLUE  (4) PAD ABDOMINAL 8 X 7.5  (2) LITE GLOVES  (1) CAUTERY TIP POLISHER LIF  (1) BLADE SURGICAL CARBON STEEL 15  (1) YANKAUER SUCTION TUBE W/0 VENT  (1 0) LAP SPONGE PREWASH 18 X 18 XRD  (1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER  (1) UNDERPAD 23 X 36  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-2492-2014",
      "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"
    }
  ]
}