{
  "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": "45 lots; 1292 units (multiple units per lot)",
      "code_info": "Product code 900-170,  45 lots:  110102563  110112615  110123042  111010248  111020273  111041096  111051368  111061709  111071957  111082061  111082257  111092361  111092454  111102694  112010081  112020399  112030637  112041196  112051864  112062443  112072782  112093724  112125027  113015544  113025946  113026104  113036753  113047198  113057812  113068156  113078518  113088755  113089018  113089196  113099566  131110068  131110400  131110579  131210963  140111411  140211740  140312329  140412793  140513106  140513245",
      "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": "OPEN HEART TRAY -   PACK-   (25) SPONGE LAP PREWASH 18\" X 18\" XRD L/F   (1) TRAY PLATO LARGE  (3) DRESSING NON ADH TELFA 8 X 3   (2) BAG GLASSINE PLAIN  (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF   (1) COVER TABLE REINFORCED 50\" X 90\" LIF  (1) NEEDLE HYPODERMIC 27G X 'h\"   (4) COUNTER NEEDLE & BLADE 10c MAG/CLEAR  (2) SYRINGE 20cc WITHOUT NDL LUER LOCK LIF   (1) JAR 16oz 500cc GRADUATE MEASURE  (2) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F   (2) PENCIL CAUTERY HAND SWITCHING LIF  (1) MARKER SKIN RULER   (2) BANDAGE ELASTIC 4\" X 5yds LIF  (2) POLISHER CAUTERY TIP LIF   (2) BANDAGE ELASTIC 6\" X 5yds LIF  (2) SYRINGE BULB 60cc CLEAR   (2) TUBE SUCTION CONNECT Y-t'' X 12' LIF  (1 0) GAUZE SPONGE 4\" X 4\" 16 PLY XRD LIF   (1) NEEDLE BLADE/KNIFE 3.0mm  (2) CONTAINER SPECIMEN 40z. WITH LID & LABEL   (1) BLADE SHARP ALL ARROUND  (1) BASIN EMESIS 10 IN 700cc   (3) CATHETER 20FR ROB NEL RED RUB  (3) BOWL UTILITY QUART 32oz LIF   (2) CATHETER THORACIC 32FR STRAIGH  (1) LABELS SET, HEPARINE, SALINE, ETC.   (2) SAFETY SCALPEL #10 DISP  (3) BASIN WASH ROUND 6QT (2) SAFETY SCALPEL #15 DISP  (2) BOWL UTILITY 16oz L/F  (1) WRAPPER 54\" X 54\" L/F  (1) CONNECTOR Y 3/8\" X 3/8\" X 3/8\"    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-2311-2014",
      "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"
    }
  ]
}