{
  "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": "3 lots/ 60 units, multiple units per lot",
      "code_info": "900-3029, 3 lots:  113099554  140312149  140613789",
      "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 Pack BOD, code 900-3029, contains:  (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill  (2) TOWEL ABSORBENT 15\" X 20\"  (1) PENCIL CAUTERY PUSH BOTTOM  (1) SYRINGE BULB 60CC  (1) TUBE SUCTION CONNECT%\" X 12'  (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG  (1) BOWL UTILITY QUART 32oz TURQ  (1) COVER MAYO STAND REINFORCED  (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER  (1) COVER TABLE REINFORCED 50\" X 90\"  (1) CUP DENTURE 8oz TEAL WITH LID  (1) RULER  (6) TOWEL CLOTH HUCK BLUE  (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK  (1) YANKAUER SUCTION TUBE WITHOUT VENT  (1) DRAPE BREAST/CHEST  (2) LITE GLOVE  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-2521-2014",
      "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"
    }
  ]
}