{
  "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": "36 lots; 936 units (multiple units per lot)",
      "code_info": "Product code 900-1146, 36 lots:  109051127  110040868  110051198  110092116  110092352  110102423  111010024  111030547  111051146  111061483  111082046  111092345  111102659  111112945  111123320  112010025  112010277  112020314  112041069  112051672  112082330  112083209  112093735  112124923  113015489  113015687  113026040  113026202  113078237  131110156  131210626  140111140  140111777  140412582  140513068  140513475",
      "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": "NEURO PACK -   (1) CAUTERY TIP POLISHER LIF  (4) DRAPE UTILITY WITH TAPE LIF  (1) INSTRUMENT POUCH  (10) LAP SPONGE PRE-WASH XRD  (1) Pk. SURGICAL STRIP W' X 6\"  (2) UTILITY BOWL 32oz  (1) MAYO TRAY LARGE  (9) SHEET DRAPE 41 \" X 69\" MEDIUM LIF  (1) NEEDLE HYPODERMIC 18G X 1 LIF  (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL  (2) Pr. SURGICAL GLOVES 7 Y2  (2) Pr. SURGICAL GLOVES 8  (2) EAR ULCER SYRINGE 2oz LIF  (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF  (1) SHEET MINOR LAP 102\" X 121\" X 78\"  (1) SAFETY SCALPEL #10  (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF  (4) CLOTH HUCK TOWELS BLUE  (1) PENCIL CAUTERY ROCKER SWITCH  (2) LEGGINS W/7'' CUFF 30\" X 42\"  (1) DRAPE% ECONOMY 53\" X 77\" LIF  (1) Pk. SURGICAL STRIP 'X\" X 6\"  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F  (2) ROUND WASH BASIN 6QT  (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE  (2) Pr. SURGICAL GLOVES 7  (1) SKIN MARKER WITH RULER LIF  (1) Pk. STERI STRIP CLOSURE %\"X 4\" LIF  (1) TUBE SUCTION CONNECT. 'X\" X 12' LIF  (1) SAFETY SCALPEL #15  (1) SAFETY SCALPEL #11L/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-2375-2014",
      "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"
    }
  ]
}