{
  "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; 1095 units (multiple units per lot)",
      "code_info": "Product code 900-1689, 20 lots:  111113026  111123373  112051861  112083402  112114645  113015432  113036419  113036729  113047214  113057427  113068155  113088752  113099277  131110194  131210755  140111165  140211884  140312435  140513104  140513464",
      "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": "CESAREAN PACK -   (1) BABY BLANKET IMP. 30\" X 30\" POLY ABS.  (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF  (1) DRESSING ISLAND 4\" x 10\"  (1) CESAREAN DRAPE 71\" x 125\" LIF  (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP  (10) LAP SPONGES PREWASH XRD LIF  (1) BABY BEANNIES  (1) SCALPEL #10 WITH HANDLE STAINLESS STEEL  (1) DRAPE SHEET 42\" X 57\" SMS  (1) EAR ULCER SYRINGE 2oz. UF  (1) RECEIVING BLANKET 100% COTTON  (1) SCALPEL #20 WITH HANDLE  (1) DURAPREP SURGICAL SOLUTION 26ml UF  (2) ABSORBENT TOWEL 15\" X 20\" L.F  (2) LITE GLOVES UF  (1) BOWL WITH LID PLASTIC 80oz.  (1) TABLE COVER REINFORCED 44\" x 78\" LIF  (1) UTILITY BOWL 32oz  (2) PAD OBSTETRICAL X-LARGE ST.  (1) WRAPPER 30\" X 30\" LIF  (1) MAYO STAND COVER REINFORCED LIF  (1) TUBE SUCTION CONNECT Y.\" X 12' UF  (1) MUCUSTRAP 20cc 1 OFR  (1) YANKAUER SUCTION TUBE WITHOUT VENT UF  (1) UMBILICAL CORD CLAMP    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-2405-2014",
      "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"
    }
  ]
}