{
  "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": "1 lot/ 16 units",
      "code_info": "900-3116, 1 lot:  131210805",
      "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 Pack FJG, code 900-3116, contains:  (2) GOWN LARGE STANDARD SMS AAMIIII  (2) TOWEL ABSORBENT 15\" X 20\"  (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG  (1) COVER MAYO STAND REINFORCED  (1) SHEET ENT SPLIT 11 0\" X 77\" SMS  (1) COVER TABLE REINFORCED 44\" X 78\"  (20) GAUZE SPONGE 4\" X 4\" 12PL Y  (6) TOWEL CLOTH HUCK BLUE  (1) PK. STRIP STERI CLOSURE W X 4\"  (2) CUP DENTURE 8oz TEAL WITH LID  (1) SKIN MARKER WITH RULER  (1) RULER  (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK  (1) SHEET o/. DRAPE 60\" X 77\" REINFORCED  (1) BLADE SURG. #15 CARBON STEEL  (1) BLADE SURG. #10 CARBON STEEL  (4) DRAPE UTILITY WITH TAPE  (1) SYRINGE BULB 60CC  (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 P/F  (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 P/F  (1) Pr. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 P/F  (1) YANKAUER SUCTION TUBE WITHOUT VENT  (1) TUBE SUCTION CONNECT%'' X 12'  (1) CAUTERY PENCIL PUSH BOTIOM HOLSTER  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-2526-2014",
      "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"
    }
  ]
}