{
  "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": "18 lots; 738 units (multiple units per lot)",
      "code_info": "Product code 900-1966, 18  lots:    113025951  113026188  113036672  113047210  113067907  113078582  113099405  113109642  113109776  131110111  131110333  131210639  140111088  140211806  140312102  140412625  140412892  140513119",
      "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": "HIGADO & PANCREA PACK -   (1) BAG SUTURE FLORAL   (2) YANKAUER SUCTION TUBE WITHOUT VENT  (4) DRAPE UTILITY WITH TAPE   (6) TOWELS CLOTH HUCK BLUE  (1) SHEET DRAPE 41 \" X 58\" SMS   (1) MAYO TRAY LARGE  (1) TABLE COVER REINFORCED 50\" X 90\"   (1) DRAPE INCISE ANTIMICROBIAL 23\" X 17\"  (1) DRAPE BARIATRIC   (1) BLADE SURGICAL #10 STAINLESS STEEL  (1) CUP SPECIMEN WITH CAP 4oz   (1) BLADE SURGICAL #15 STAINLESS STEEL  (30) LAP SPONGE PREWASH 18\" X 18\" XRD   (1) STRIP STERI CLOSURE W X 4\"  (1) POLISHER CAUTERY TIP   (1) NEEDLE ECLIPSE 22 X 1 Y2  (4) TOWEL ABSORBENT 15\" X 20\"   (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK  (2) LITE GLOVE   (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER  (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR   (1) FORCE TRIVERSE  (1) SYRINGE BULB 60CC   (1) BLADE EXTENDED ELECT. 16.51cm  (2) TUBE SUCTION CONNECT Y.\" X 12'   (2) CHLORAPREP 26ML APPLICATOR TEAL  (1) TABLE COVER BTC 77\" X 110\" HD FULL COVERAGE    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-2423-2014",
      "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"
    }
  ]
}