{
  "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": "1 lot ,6 units placed on hold at the firm",
      "code_info": "Product code 900-2415 ,1 lots  140412654",
      "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": "TOTAL HYCTERECTOMY      (I)   CANNULA 5MM XCEL SLEEVES LIF ( I )  TROCAR XCEL BLADELESS II MM  (I)  TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I)   NEEDLE ULTRA VERES 120MM LIF  ( I)   TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF  (I)  DRAPE VIDEO CAMERA 13cm X 244 em LIF  ( I )   DRAPE LAP ABDOM W/POUCH 1 02\" X 1 22\" X 78\" STD SMS  (2)   LEGGINGS W/7\" CUFF 30'' X 42\" ( I )   SAFETY SCALP EL # II S/STEEL  ( I )  GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I )  TABLE COY ER REINFORCED 50\" X 90\"  LIF  (4)   DRAPE UTILITY WIT APE LIF  (2)  DRAPE SI-IEET 42\" X 57\" SMS  (I) TUBE SUCTION CONNECT Y.\" X 1 2' LIF  ( I )  MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF (4)  TOWELS ABSORBENT 1 5\" X 20\" LIF  (2)   LITE GLOVE  ( I )   DRAPE UNDERBUTTOCK W/ PO UCl-144\" X 35\" (2)  SYRINGE I Occ W/0 NEEDLE LILOCK LIF  (2)  SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18'' X 1 8\" XRD LIF\t  ( I )  PVP PAINT 8\" STICK SPONGE  ( I )    UTILITY BOWL QUART 32oz LIF ( I )    ELECTRODE DUAL DEPRES  ( I)    DRESSING OPSITE POST PO 2!12 X 2\"  ( I )   MERLINO SK IN PREP APPLIC. 39ML LIF  (3)   GOWM XL SMS IMPERVIOUS REINFORCED LIF  ( I )   CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING    (1)  FOLEY CATHETER KIT CONTAINING:  (I)   CATHETER 1 6FR FOLEY 2WAY, Sec  (I)\tPYP TR IPLE SWABSTICK IODOPHOR (2) \tSWABSTICK DRY COTTON  ( I ) \tSYR I NGE IOcc WATERFREFIL LIF  (2) \t GLOVE MED FREETOUCH YYN I L P/F (I) \tTOWEL3PLYPOLY 17\" X 18\"  (I)\tDRAPE 4\" FENESTRATED 18\" X 26\" (I)\tLABEL lD  PATIENT  (I)\tJELLY LUBRI CATING FIVE GRAM  ( I ) \t URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) \tTRAY SBS  ( I ) \tWRAPPER 24\" X 24\"    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-2454-2014",
      "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"
    }
  ]
}