{
  "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/48 units, multiple units per lot",
      "code_info": "900-3114, 2 lots:  131210804  140111438",
      "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": "Tummy Tuck Pack- FJG, code 900-3114, contains:  (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill  (2) TOWEL ABSORBENT 15\" X 20\"  (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER  (1) NEEDLE HYPODERMIC 22G X 1 Y2  (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK  (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG  (2) BOWL UTILITY QUART 32oz.  (1) COVER MAYO STAND REINFORCED  (2) MARKER SKIN WITH RULER  (1) RULER  (1) COVER TABLE REINFORCED 50\" X 90\"  (2) CUP DENTURE 8oz TEAL WITH LID  (6) TOWEL CLOTH HUCK BLUE  (1) TUBE SUCTION CONNECT X\" X 12'  (1) YANKAUER SUCTION TUBE WITHOUT VENT  (1) SHEET% DRAPE REINFORCED 60\" X 77\"  (4) DRAPE UTILITY WITH TAPE  (1 0) LAP SPONGE PREWASH 18\" X 18\" XRD  (1) BLADE SURG. #15 CARBON STEEL  (1) BLADE SURG. #1 0 CARBON STEEL  (1) SYRINGE BULB 60cc  (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F  (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F  (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F  (1) SKIN STAPLE 35 WIDE  (1) DRAPE TOP WITH ADHESIVE 108\" X 50\" STD SMS  (2) DRAPE SIDE 42\" X 76\" WITH TAPE  (1) DRAPE BOTIOM ABS REINFORCED 71\" X 62\" STD SMS WITH TAPE  (1 0) GAUZE SPONGE 4\" X 4\" 16 PLY  (1) PK. STRIP STERI CLOSURE W X 4\"  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-2524-2014",
      "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"
    }
  ]
}