{
  "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": "11 lots/432 units, (multiple units per lot)",
      "code_info": "Product code 900-2164, 11 lots  112041224  112083167  113036762  113047217  113067914  113078468  113088852  131210646  140312118  140412645  140513125",
      "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": "FEMORAL PACK   CONTENTS:\t  (2)  TOWELS ABSORBENT 15\" X 20\" LIF (2)   DRAPE SHEET 42\" X 57\" SMS LIF  (1)   SAFETY IV INTROCAN 18 X 1X  ST. LIF  (2)  GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2)  VESSEL LOOP SURGICAL MAXI BLUE  (1)  SUTURE AID BOOT STD YELLOW ST. LIF  (1)  YANKAUER SUCTION TUBE WITHOUT VENT L/F  (1)   EMESIS BASIN 101N 700cc LIF (2)   LIGHT SHIELD  (1)   NEEDLE HYPODERMIC 18G X 1 L/F (1)  CATHETER IV SAFETY 20G X 1X LIF  (1)   DRAPE T LAPAROT 102\" X 78\" X 121\" SMS STD LIF (10) LAP SPONGE PREWASH 18\" X 18\" XRD LIF  (1)   MAYO STAND COVER REINFORCED LIF (1)  STOCKINETTE IMPERVIOUS 14\" X 48\" LIF  (2)  SYRINGE 20cc WITHOUT NEEDLE   LUER I LOCK LIF (1)  SUTURE BAG FLORAL LIF  (2)   UTILITY BOWL 16oz. L/F  (1)  CAUTERY TIP POLISHER LIF  (1)  TABLE COVER REINFORCED 50\" X 90\" LIF (4)   DRAPE UTILITY WITH TAPE LIF  (1)   MAYO TRAY SMALL  (1) SCALPEL SAFETY WEIGHTED #15 (1)  SCALPEL SAFETY WEIGHTED #11  (2)  TUBE SUCTION CONNECT  X\" x 12' LIF  (2)   NEEDLE & BLADE COUNTER, 1Oc MAG/CLEAR LIF (1)  TIME OUT BEACON NON WOVEN ST.  LIF  (1)  SKIN MARKER INK W/8 LABEL/TIME OUT/RULER L/F      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-2436-2014",
      "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"
    }
  ]
}