{
  "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": "2026-09-16",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Covington",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98840",
      "recalling_firm": "C.R. Bard Inc",
      "address_1": "8195 Industrial Blvd Ne",
      "address_2": "",
      "postal_code": "30014-1497",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Costs Rica, Guatemala, Mexico, Saudi Arabia, and United Arab Emirates.",
      "recall_number": "Z-3116-2026",
      "product_description": "Products that contain the Pericare Wipes:  *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray REF: 300316A UDI codes: 00801741024344¿\t10801741024341  *Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252¿\t10801741024259 00801741024269\t10801741024266 00801741024276¿\t10801741024273  *SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314A UDI codes: 00801741073724¿\t10801741073721 REF: A300314AC (Canada Only) UDI-DI code: 00801741143243  *SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316A UDI code: 00801741073731\t10801741073738  *SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300318A UDI code: 00801741073748¿\t10801741073745  *SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ REF: A303314A A303316A A303318A UDI code: 00801741073786¿\t10801741073783 00801741073793¿\t10801741073790 00801741073809¿\t10801741073806  *SureStep\" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A303414A UDI code: 00801741073816¿\t10801741073813  *(416A)SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ (714A/716A/718A)SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ (914)SureStep\" Foley Tray System REF: A304716A A304714A A304716A A304718A UDI code: 00801741104206¿\t10801741104203 00801741104268\t10801741104265 00801741104299¿\t10801741104296 00801741100376¿\t10801741100373  *SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319416A UDI code: 00801741100307¿\t10801741100304  *SureStep\" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319416AM UDI code: 00801741073861¿\t10801741073868  *SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ REF: A319418A UDI code: 00801741100314¿\t10801741100311  SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ REF: A903316A UDI code: 00801741096600¿\t10801741096607 \t ***** SureStep\" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A300414A UDI code: 00801741073755\t10801741073752  SureStep\" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319414AM UDI code: 00801741073854\t10801741073851  SureStep\" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter REF: A319418AM UDI code: 00801741073878\t10801741073875  SureStep\" Foley Tray System Bardex¿ IC Complete Care REF: A903318A UDI code: 00801741104657\t10801741104654            For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.",
      "product_quantity": "212580",
      "reason_for_recall": "Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.",
      "recall_initiation_date": "20260625",
      "center_classification_date": "20260904",
      "report_date": "20260916",
      "code_info": "Bardex¿ I.C. Complete Care¿ Foley Catheter Tray 300316A / 00801741024344¿ 10801741024341 Lot Number: NGKT3657  Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter 303314A / 00801741024252¿ 10801741024259 Lot Number: NGKU4153 303316A / 00801741024269 10801741024266 Lot Number: NGKW2883 303318A / 00801741024276¿ 10801741024273 Lot Number: NGKU0966  *SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ A300314A / 00801741073724¿ 10801741073721 Lot Number: NGKU1020 A300314AC (Canada Only) / 00801741143243 Lot Number: ****  SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ A300316A / 00801741073731 10801741073738 Lot Numbers: NGKT2448 NGKT3221 NGKT3288 NGKT3301 NGKT3315 NGKU2921 NGKV0293  SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ A300318A / 00801741073748¿ 10801741073745 Lot Number: NGKT2493  SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ A303314A / 00801741073786¿ 10801741073783 Lot Numbers: NGKT3222 NGKV0249 A303316A / 00801741073793¿ 10801741073790 Lot Numbers: NGKU0894 NGKU0947 NGKU0973 NGKU1021 NGKU1748 NGKU1826 NGKU1830 NGKU2034 NGKU2035 NGKU2996 NGKU3042 NGKU3969 NGKU4037 NGKU4077 NGKU4078 NGKU4135 NGKU4713 NGKU4714 NGKU4720 NGKU4721 NGKU4722 NGKU4727 NGKV2390 NGKV3390 A303318A / 00801741073809¿ 10801741073806 Lot Numbers: NGKT3223 NGKU4136  SureStep\" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A303414A / 00801741073816¿ 10801741073813 Lot Number: NGKU1022  (416A)SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ (714A/716A/718A)SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ (914)SureStep\" Foley Tray System A304716A / 00801741104206  10801741104203 Lot Number: NGKT2496 A304714A / 00801741104268 10801741104265 Lot Number: NGKU2923 A304716A / 00801741104299  10801741104296 Lot Numbers: NGKU1833 NGKU4729 A304718A / 00801741100376¿ 10801741100373 Lot Numbers: NGKT3224 NGKU3971  SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ A319416A / 00801741100307¿ 10801741100304 Lot Number: NGKS1605  SureStep\" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319416AM / 00801741073861¿ 10801741073868 Lot Numbers: NGKT2390 NGKT2410 NGKT3225 NGKT3319 NGKU0951 NGKU0977  SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ A319418A / 00801741100314¿ 10801741100311 Lot Number: NGKT2411  SureStep\" Foley Tray System Bardex¿ IC Complete Care¿ A903316A / 00801741096600¿ 10801741096607 Lot Numbers: NGKT3392 NGKU2020  **** SureStep\" Foley Tray System Lubri-Sil¿ IC Complete Care A300414A / 00801741073755 10801741073752 Lot Number: NGKV3524  SureStep\" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319414AM / 00801741073854 10801741073851 Lot Number: NGKV3487  SureStep\" Foley Tray System Bardex¿ I.C. Complete Care Foley Catheter A319418AM / 00801741073878 10801741073875 Lot Number: NGKV4983  SureStep\" Foley Tray System Bardex¿ IC Complete Care A903318A / 00801741104657 10801741104654 Lot Number: NGKV2397",
      "more_code_info": ""
    }
  ]
}