{
  "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": "21 lots; 680 units (multiple units per lot)",
      "code_info": "Product code 900-920, 21 lots:  111051217  111092406  112030888  112052022  112093734  112114584  112125309  113015700  113036806  113057750  113078593  113089210  113099376  113099582  131010028  131110283  140111258  140211862  140312427  140412918  140513470",
      "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": "PLASTIC SURGERY PACK-   (1) MAYO STAND COVER REINFORCED LIF  (1) CAUTERY TIP POLISHER LIF  (1) BAG SUTURE FLORAL L/F  (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF  (20) GAUZE SPONGES 4\" X 4\" 4PL Y  (1) COVER TABLE REINFORCED 50\" X 90\" LIF  (2) GOWN IMPERVIOUS REINFORCED LARGE SMS  (1) PENCIL CAUTERY HANDSWITCHING L/F  (1) TUBE SUCTION CONNECT. ~, X 12' LIF  (1 0) LAP SPONGE PRE-WASH XRD LIF  (2) LITE GLOVE LIF  (4) HUCK CLOTH TOWEL BLUE  (2) DRAPE SHEET MEDIUM 41\" X 69\" LIF  (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF  (1) DRAPE LAP ABDOMINAL WITH POUCH STD SMS  (5) Pk. STERI STRIP CLOSURE %\"X 4\" L/F  (1) MAGNETIC INST. DRAPE  (3) SKIN MARKER WITH RULER LIF  (1) EXTENDED ELECTRODE BLADE  (2) ABSORBENT TOWEL 15\" X 20\" LIF  (4) UTILITY BOWL 32 oz  (2) SURGEON GLOVES #8 BIOGEL    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-2358-2014",
      "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"
    }
  ]
}