{
  "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": "6 lots,132 units (multiple units per package)",
      "code_info": "Code 900-2765, 6 lots  112124939  113036441  113056798  113057644  113078320  113088806",
      "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 SPINE PACK  , CODE 900-2765  CONTENTS:  (l )   DRAPE INCISION 23\" X 1 7\" \t  (I)   SCALPEL  W/HANDLE # 15 S/STEEL   (I)    INSTRUMENT POUCH 7 X 1 1  2 COMPART   (I)   Pk. STRIP SURGICAL W' X 6\"  (I)  CAUTERY  PENCIL HAND SWITCHING LIF\t  (4)    UTILITY DRAPE W/TAPE L/F  (I)   SCALPEL W/HANDLE # 10 S/STEEL \t  (I)    TUBE SUCTION CONNECT W' X I 2' LIF  (I)   SKIN MARKER W/RULER \t  (2)    SPECIMEN  CONTAINER4oz W/LID & LABEL   (I)   SOLUTION  SURGICAL  DURAPREP  26ML  LIF\t  (I)     YANKAUER SUCTION TUBE W/0 VENT LIF  (I)   MAYO  TRAY LARGE \t  (2)    NEEDLE & BLADE COUNTER  lOc MAG/CLEAR   (I)   DRAPE INCISE ANTIMICROBIAL 23\" X 1 7\" LIF\t  (2)    SYRINGE  I Occ W/0 NEEDLE  LUER LOCK LIF   (I)    J VAC RESERVOIR 300ML   (2)    LITE GLOVE LIF  (2)    CAUTERY  TIP  POLISHER  LIF\t  (2)    TABLE COVER BTC 77\" X 110\" HD  FULL  L/F   (20)  GAUZE SPONGE  4\" X 4\" 16PLY XRD LIF\t  (4)    TOWELS ABSORBENT  1 5\" X 20\" LIF  ( I )   DRAPE  T LAPAROTOMY  102\" X 78\" X 1 21\" STD SMS (5)   LAP SPONGE  PREWASH 18\" X 18\" XRD LIF   ( I)    SUTURE  BAG FLORAL \t  (5) DRAPE  'l'4   ECONOMY 53\" X 77\" LIF  (3) GOWN IMPERVIOUS  EXTRA REI NF. LGE T/WRAP\t  (I)   UTILITY BOWL 1 6oz LIF  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-2504-2014",
      "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"
    }
  ]
}