{
  "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": "5 lots/ 32 units, multiple units per lot",
      "code_info": "900-3083, 5 lots:  113109930  131210851  131210953  140111437  140312196",
      "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": "Face Lift , Code 900-3083, contains:  (I) SHEET ENT SPLIT 110\" X 77\" LIF  (I) COVER TABLE REINFORCED 50\" X 90\" LIF  (I) DRAPE HEAD WITH TAPE 44\" X 26\" LIF  (I) COVER MAYO STAND REINFORCED LIF  (I) BAG SUTURE FLORAL LIF  (3) GOWN STANDARD LARGE SMS VEL/NE  LABEL SAMPLE  (I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF  ( I) STAPLE SKIN 35 WIDE LIF  ( I) TUBE SUCTION CONNECT W' X 12' L/F  ( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (2) BLADE # I5 CARBON RIB  ( I) NEEDLE SPINAL ANEST22G X 3\\12 LIF  ( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF  (2) *PR. GLOVE SURG. 6.5 POWDER LATEX  (I) GUT PL FAST ABSORB 5-0  (2) SUTURE 2.0 VICRYL 25MM  (3) TOWELS ABSORBENT 15\" X 20\" LIF  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-2522-2014",
      "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"
    }
  ]
}