{
  "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, 306 units, multiple units per lot",
      "code_info": "Code 900-2658, 3 lots  112062217  112093595  112093720",
      "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 MRT, code 900-2658, contains:  ( 1) BULB SYRINGE 60cc  (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE  ( 1) CAUTERY PENCIL PUSH BOTTOM  (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK  ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG  ( 1) UTILITY BOWL QUART 32oz  ( 1) MAYO STAND COVER REINFORCED  ( 1) TABLE COVER REINFORCED 50 X 90  ( 1) DRAPE BREAST/CHEST SMS  ( 1) YANKAUER SUCTION TUBE W/0 VENT  ( 1) TUBE SUCTION CONNECT Y  ( 1) RULER 6 CLEAR  (6) TOWEL CLOTH HUCK C (BLUE)  (2) TOWEL ABSORBENT 15 X 20  (2) SKIN MARKER INK W/ LABEL  ( 1) DENTURE CUP 8oz W/LID  (2) LITE GLOVES  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-2491-2014",
      "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"
    }
  ]
}