{
  "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": "12 lots/256 units, (multiple units per lot)",
      "code_info": "Product code 900-2256, 12 lots  112041300  113026058  113047204  113057738  113078309  113088794  113109793  131110244  131110291  140111095  140412649  140513128",
      "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  CONTENTS:  (4)   TOWEL ABSOSRBENT 15\" X 20\" LIF   ( I )   BAG BI OH AZARD 30\" X 37\"  (2)   MAYO STAND COYER REINFORCED UF  (20) GAUZE SPONGE 4\" X 4\" 1 6PLY XRD UF  ( I )   CAUTERY POLISHER TIP LIF  ( I )    BLADE SU RGICAL# II CARBON STEEL   (I)    TRAY MAYO LARGE  (8)   TOWELS CLOTH I-l UCK (BLUE)   (2)   WASH BASIN ROUND 6QT  ( I )   NEEDLE HYPODERMIC 1 8G X I \\12 ST.   (2)   UTI LITY BOWL QUART 32oz.  (2)   BULB SYRINGE 60cc LIF  (2)   NEEDLE & BLADE COUNTER,  IOC  M/CLEAR LIF   (2)   PVP SCRUB 8'' STICK SPONGE ST.  (I)SKIN STAPLE 35 WIDE ST. LIF  (2)   SYRINGE 60ML W/0 NEEDLE LILOCK LIF  (2)   LITE GLOVE  (I)    TABLE COYER BTC 79\" X 110\" HD FULL COVERAGE LIF\t  (2)   TUBE SUCTION CONNECT. W'  X 1 2' LIF (4)   DRAPE UTILI TY WIT APE LIF  (5)   LAP SPONGE PREWASH 1 8\" X 1 8\" XRD LIF   (I) CAUTERY PENCIL ROCKER SWITCH UF   (2)   BLADE SURG I CA L # I O  CARBON STEEL  (I)    BLADE SURG I CAL#1 5 CARBON STEEL  (I) SKIN MARKER INK W/8 LABEL   (3)   UTI LITY BOWL 1 6oz. L/F  (2)   PVP PAINT 8\" STICK SPONGE ST.   (7)   DRAPE :V. ECONOMY 53\" X 77\" LIF  (I)S UTURE BAG FLORAL  (I) SY RINGE I Occ SLI P TI P ST. LIF  (I) NEEDLE HYPODERM IC 22G X I \\12  ST.  (I) SOLUTION SURG I CAL DURAPREP 26M L LIF  (I) GOWN SURG. REINFORCED LGE TOWEL/ WRAP  (2)   GOWN FAB REINFORCED X-LARGE SONTARA  (I) DRAPE  TLAPAROT. 1 02\" X 78\" X 1 21 \" STD SMS      Product Usage:  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-2443-2014",
      "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"
    }
  ]
}