{
  "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": "7 lots/96 units, (multiple units per lot)",
      "code_info": "Product code 900-2385 ,7 lots  112041304  112093771  113057712  113078586  113099428  120051955  140613805",
      "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": "VAGINAL PROCEDURE  PACK  CUSTOM ED  CONTENTS:\t  (1)   DRAPE LITHOTOMY 110\" X 63\" W/LEGGINGS I POUCH FEN 3 X 6  SMS LIF (1)    GOWN XL SMS IMPERV. REINFORCED  LIF  (1)    COVER MAYO STAND REINFORCED  LIF (1)    BAG SUTURE FLORAL  (1)  COVER TABLE REINF 50\" X 90\" LIF  (1)  TUBE SUCTION CONNECT. W' X 12' LIF (1) \tGOWN SURG REINF XL T/WRAP  (20) GAUZE SPONGE 4\" X 4\" 16 PLY XRD LIF (1) \tPENCIL CAUTERY HAND SWITCHING  (1) \tPVP PAINT 8\" STICK SPONGE  (1) \tPVP SCRUB 8\" STICK SPONGE  (1) \tSYRINGE 20cc W/0 NDL LUER LOCK LIF (1)   TOWEL ABSORBENT 15\" X 20\" LIF  (1)    YANKAUER SUCTION TUBE W/0 VENT LIF (1)   PRE PAD WITH CUFF  (1) \tPACKING VAGINAL XRD 4\" X 36\" 8PLY (2) \tPAD OBSTETRICAL XL  (1) \tCATHETER 2/W 16Fr. PRESS W/UBAG 2000ML (1)   TIME OUT BEACON NON WOVEN 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-2453-2014",
      "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"
    }
  ]
}