{
  "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": "23 lots; 1966 units (multiple units per lot)",
      "code_info": "Product code 900-848,  23 lots:  112041259  112072813  112072916  112114685  112124855  112125308  113015569  113047034  113047207  113057642  113067938  113068189  113078590  113099301  113109648  113109876  131110346  140111253  140211856  140312186  140412473  140513146  140513482",
      "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 -   CONTENTS:   ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF  ( 1) MAYO STAND COVER REINFORCED LIF  (1) BAG SUTURE FLORAL LIF  (4) DRAPE UTILITY WITH TAPE LIF  (2) DRAPE SHEET 41 II X 58\" SMS L/F  ( 1) TABLE COVER 50\" X 90\" LIF  ( 1) SOLUTION SURGICAL DURAPREP 26ML LIF  (1) BLADE SURGICAL# 10 CARBON STEEL  (5) LAP SPONGE PREWASH 18\" X 18' XRD LIF  (6) TOWELS ABSORBENT 15\" X 20\" LIF  ( 1) CAUTERY TIP POLISHER L/F  (2) UTILITY BOWL 16oz LIF  (1) TUBE SUCTION CONNECT%\" X 12' LIF  (2) NEEDLE & BLADE COUNTER 10c MAG /CLEAR LIF  (1) DRAPE T LAPAROTOMY 102\" X 78\" 121\" SMS STD LIF  ( 1) SPECIMEN CONTAINER 4oz WITH LID & LABEL  ( 1) YANKAUER SUCTION TUBE WITHOUT VENT LIF  ( 1) TIME OUT BEACON NON WOVEN LIF  ( 1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP 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-2353-2014",
      "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"
    }
  ]
}