{
  "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; 800 units (multiple lots per unit)",
      "code_info": "Product code 900-1300, 20 lots:  109050993  112051747  112093868  112104141  112124943  113015633  113025937  113036226  113046883  113047325  113057419  113078249  113099270  113109990  131110171  140111097  140211640  140312065  140412551  140513082",
      "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 -   (1) BAG SUTURE FLORAL   (1) COVER TABLE 44\" X 90\"  (4) ABSORBENT TOWELS 15\" X 20\" UF   (1) LAPAROTOMY T DRAPE 102\" X 78\" X 121\" STD SMS  (4) DRAPE UTILITY WITH TAPE LIF   (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP  (1) DURAPREP SURGICAL SOLUTION 26mL UF   (1) INCISION DRAPE 23\" x 17\"  (1) INSTRUMENT POUCH   (2) CAUTERY TIP POLISHER LIF  (1) CAUTERY PENCIL HANDSWITCHING LIF   (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL  (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF   (2) LITE GLOVES LIF  (1) TUBE SUCTION CONNECT. Y..\" X 12' LIF   (1) SKIN MARKER WITH RULER  (1) INCISE DRAPE ANTIMICROBIAL 23\"x17\" LIF   (1) Pk SURGICAL STRIP W'X 6\"  (5) LAP SPONGES PRE-WASH 18\" X 18\" XRD L/F   (20) GAUZE SPONGE 4\"X 4\" 16 PLY XRD LIF  (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL    (5) DRAPE % ECONOMY 53\" X 77\" LIF  (2) TABLE COVER HD 77\" X 110\" L!F   (1) MAYO TRAY LARGE  (1) UTILITY BOWL 16 oz LIF   (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F  (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF   (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL  (1) J VAC RESERVOIR 300 mL    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-2387-2014",
      "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"
    }
  ]
}