{
  "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": "26 lots; 2192 units (multiple units per lot)",
      "code_info": "Product code 900-414, 26  lots:  112030868  112041328  112051656  112062284  112072802  112093940  112104108  112114600  113015696  113025963  113036361  113036800  113057485  113068047  113068170  113088863  113089072  113099574  131110261  131210813  140111100  140211669  140311938  140412466  140412887  140513363",
      "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": "LAPAROSCOPY CHOLE PACK -  -  ( 1) STRIP STERI CLOSURE W' X 4\" LIF  ( 1) TABLE COVER REINFORCED 50\" X 90\" LIF  ( 1) DRAPE LAP ABDOMINAL W/POUCH 102\" X 122\" X 78\" LIF  (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF  ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F  (5) TOWELS ABSORBENT 15\" X 20\" LIF  (5) LAP SPONGE PREWASH 18\" X 18\" XRD LIF  (4) DRAPE UTILITY WIT APE LIF  ( 1) COVER CAMERA W/ELAST LIF  (2) GAUZE SPONGE 4\" X 4\" 12PL Y LIF  ( 1) NEEDLE ULTRA VERES 120mm LIF  (2) DRAPE SHEET 41 \" X 58\" SMS LIF  ( 1) SCALPEL WEIGHTED SAFETY #11  ( 1) TUBING INSUFFLATING OPEN TIP W/0 VENT LIF  ( 1) DRESSING TEGADERM 4\" X 4 %\" LIF  ( 1) TUBE SUCTION CONNECT X\" X 12' LIF  ( 1) MAYO STAND COVER REINFORCED LIF  ( 1) SUTURE BAG FLORAL LIF  ( 1) Pk. STERI STRIP LAP SET LATEX  ( 1) CORD LAPAROSCOPY MONOPOLAR LIF  ( 1) MAYO TRAY SMALL LIF  ( 1) TIME OUT BEACON NON WOVEN ST. LIF  (1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF  ( 1) BAG ZIP LOCK PLASTIC 6\" X 10\"  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-2323-2014",
      "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"
    }
  ]
}