{
  "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": "34 lots; 3603 units (multiple units per lot)",
      "code_info": "Product code 900-996, 34 lots:  111040982  111051305  111061694  111071947  111082120  111092410  111092465  111102789  111113147  111123308  112010213  112020496  112030757  112041365  112052027  112072880  112083444  112093958  112114585  112125124  113025974  113036393  113057517  113057612  113057822  113078480  113078577  113099300  113099581  131110081  131110607  140111262  140211738  140513485",
      "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": "LAPAROTOMY PACK-     (1) MAYO STAND COVER REINFORCED LIF  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (5) LAP SPONGES PRE-WASH 18\" X 18\" XRD LIF  (1) LITE GLOVE LIF  (1) BAG SUTURE FLORAL  (1) BLADE SURGICAL #1 0 CARBON STEEL  (1) BLADE SURGICAL #15 CARBON STEEL  (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF  (1) CAUTERY TIP POLISHER LIF  (1) BAG GLASSINE  (1) TABLE COVER 44\" X 90\" L/F  (2) DRAPE SHEET 41 \" X 58\" SMS  (1) LAPAROTOMY DRAPE \"T\" 102\" X 78\" X 121\" STD SMS  (4) DRAPE UTILITY WITH TAPE LIF  (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF  (1) TUBE SUCTION CONECT W' X 12' LIF  (3) ABSORBENT TOWELS 15\" X 20\" LIF  (1) CAUTERY PENCIL PUSH BOTTON  (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill  (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF    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-2364-2014",
      "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"
    }
  ]
}