{
  "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": "2 lots; 153 units (multiple units per lot)",
      "code_info": "Product code 900-741A,  2 lots:  140412701  112104102  113015459  113025775  113036381  113036466  113067962  113078344  113088941  113099578  113109870  131110274  131210840  140111249  140211736",
      "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": "ORTHO IMPLANT SURGICAL PACK -   (1) CAUTERY TIP POLISHER   (1) U-DRAPE 60\" X 70\" WITH TAPE SPLIT 6\" X 21\"  (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8\" X 7 Y:z\"  (1) TUBE SUCTION CONNECT. }4\" X 12'   (1) DURAPREP SURGICAL SOLUTION 26ml  (1) BAG GLASSINE   (1) YANKAUER SUCTION TUBE WITHOUT VENT  (2) LITE GLOVE   (1) SPLIT SHEET WITH ADHES 1 08\" X 77\" STD SMS  (2) COVER TABLE BTC 77\" X 86\" HD FULL COVERAGE   (1) STOCKINETTE IMPERVIOUS 14\" X 48\"  (1) MAYO STAND COVER REINFORCED   (1) INCISE DRAPE ANTIMICROBIAL 23\" X 17\"  (5) ABSORBENT TOWELS 15\" X 20\"   (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV  (4) DRAPE UTILITY   (1) CAUTERY PENCIL ROCKER SWITCH  (5) LAP SPONGES PREWASH XRD   (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE  (2) DRAPE SHEET 70\" X 100\" STD SMS   (1) TIME OUT BEACON NON WOVEN  (1) STAPLE SKIN WIDE 35 ST.   (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER  (1) MAYO TRAY LARGE   (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG  (1) TOP DRAPE W/ADHES. 100\" X 53\" SMS   (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP  (2) BANDAGE ELASTIC 6\" X 5\"yds   (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK  (1) UTILITY BOWL 16oz   (1) NEEDLE HYPODERMIC 18G X 1Y2  (2) UTILITY BOWL 32oz   (2) BLADE SURGICAL# 10 STAINLESS STEEL    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-2347-2014",
      "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"
    }
  ]
}