{
  "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": "60 lots; 4896 units (multiple units per lot)",
      "code_info": "Product code 900-548, 60 lots:  109010181  109030603  109051042  109061206  109071558  109081861  109092069  109102334  109112579  109122695  110010096  110020395  110030677  110040948  110051248  110051360  110061461  110071847  110082073  110092262  110092399  110112663  110123108  111010139  111020289  111030691  111040905  111051209  111061555  111071826  111082102  111092553  111102766  111123268  112010186  112020489  112030845  112041337  112051995  112062490  112072805  112083434  112093640  112104099  112114678  113015454  113036442  113047025  113047205  113057493  113057747  113068175  113088875  113099441  113109856  131110266  131210828  140111238  140211731  140211940",
      "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": "PERY GYN PACK -    (1) TABLE COVER REINFORCED 44\" X 78\" UF   (2) TOWEL ABSORBENT 15\" X 20\" LIF  (2) GOWN LARGE SMS IMPERVIOUS REINFORCED   (1) DRAPE UNDERBUTTOCK WITH POUCH  (1) UTILITY BOWL 16oz.   (10) GAUZE SPONGE 4\" X 4\" 16PL Y XRD UF  (1) ROBNEL CATHETER 18FR.   (1) DRAPE SHEET 41 \" X 58\" SMS  (2) LEGGINS WITH 7\" CUFF 30\" X 42\"   (1) DRAPE UTILITY WITH TAPE UF    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-2331-2014",
      "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"
    }
  ]
}