{
  "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": "20 lots; 440 units (multiple units per lot)",
      "code_info": "Product code 900-1738, 20  lots:  111030607  111051369  111061590  111071991  111082066  111102866  111113031  111123419  112010088  112020406  112030643  112041201  112051875  112083056  112093914  112114648  113088760  113089083  140211651  140312085",
      "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": "UROLOGY PACK -   (4) ABSORBENT TOWELS UF   (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV  (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F  (1) TUR Y SET, 81 \"2 .1M REGULAR CLAM  (1) TABLE COVER 44\" x 90\"   (1) DRAPE LITHO 11 0\" X 63\" WITH POUCH /LEGGING FEN  (1) TUBE SUCTION CONNECT. Y.\" X 12' LIF   (1) WASH BASIN ROUND 6QT  (1 0) GAUZE SPONGE 4\" X 4\" 16PL Y LIF   (1) BAG URINARY DRAINAGE 2000ml ANTI-REFLUX LIF  (1) DRAPE LASER CAMERA W/EL UF   (1) SYRINGE 1 Occ W/0 NDL LUER LOCK UF  (1 ) UTILITY BOWL 32oz.   (1) GEL SYRINGE 10cc PREFILLED  (5) SPECIMEN CONTAINER 4oz. W/LID & LABEL L/F   (1) WRAPPER 20\" X 20\" L/F    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-2410-2014",
      "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"
    }
  ]
}