{
  "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-3114-2026",
      "product_description": "Products that contain the Pericare Wipes:    Bardex Lubricath Foley Catheter Tray  REF:  899914  899916  899918  UDI codes:  00801741024801¿\t10801741024808  00801741024818¿\t10801741024815  00801741024825¿\t10801741024822    SureStep\" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter  REF: A119416M  UDI code: 00801741073700\t10801741073707  \t  SureStep\" Foley Tray System Bard¿ Lubricath Foley  REF: A800361  UDI code: 00801741073939\t10801741073936  \t  SureStep\" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray  REF: A899616  UDI code: 00801741104534¿\t10801741104531    SureStep\" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter  REF: A899914  UDI code: 00801741074004\t10801741074001    SureStep\" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter  REF: A899916  UDI code: 00801741074011¿\t10801741074018    SureStep\" Foley Tray System Bardex¿ Lubricath¿ Temperature Sensing Catheter  REF: A900216  UDI code: 00801741120978¿\t10801741120975    SureStep\" Foley Tray System Bard¿Lubricath¿ Foley Catheter  REF:  A902914  A902916  A902918  UDI code:  00801741074066¿10801741074063  00801741074073\t10801741074070  00801741074080¿10801741074087    Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter  REF: 304916  UDI code: 00801741019736\t01801741019739    Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter  REF: 902916  UDI codes: 00801741024863\t10801741024860    (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete  REF:  A304914  A304916  A304918  UDI codes:   00801741104350¿\t10801741104357  00801741104367¿\t10801741104364  00801741100499¿\t10801741100496    SureStep\" Foley Tray System Bard¿ Lubricath Foley  REF: A800365  UDI codes: 00801741073960\t10801741073967    SureStep\" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter  REF: A899918  UDI codes: 00801741074028\t10801741074025    SureStep\" Foley Tray System Bard¿Lubricath¿ Foley Catheter  REF: A902618  UDI codes: 00801741104640\t10801741104647    SureStep\" Foley Tray System Bard¿Lubricath¿ Foley Catheter  REF: A902616  UDI codes: 00801741104633¿\t10801741104630    SureStep Intermittent Catheter Tray  REF: INTL16C  UDI codes: 00801741183195¿\t10801741183192  \t  \t  \t  \t  \t        For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.",
      "product_quantity": "12,463 trays/kits",
      "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": "Catalog Numbers  / UDI codes: 899914 / 00801741024801¿ 10801741024808 Lot Number: NGKU4611  899916 / 00801741024818¿ 10801741024815 Lot Numbers: NGKU2448 NGKU4610  899918 / 00801741024825¿ 10801741024822 Lot Number: NGKU3555  ***** SureStep\" Foley Tray System with Bardex¿ Lubricath Temp Sensing Foley Catheter REF: A119416M UDI code: 00801741073700 10801741073707   SureStep\" Foley Tray System Bard¿ Lubricath Foley REF: A800361 UDI code: 00801741073939 10801741073936   SureStep\" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A899616 UDI code: 00801741104534¿ 10801741104531  SureStep\" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899914 UDI code: 00801741074004 10801741074001  SureStep\" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899916 UDI code: 00801741074011¿ 10801741074018  SureStep\" Foley Tray System Bardex¿ Lubricath¿ Temperature Sensing Catheter REF: A900216 UDI code: 00801741120978¿ 10801741120975  SureStep\" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902914 A902916 A902918 UDI code: 00801741074066¿10801741074063 00801741074073 10801741074070 00801741074080¿10801741074087  Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 304916 UDI code: 00801741019736 01801741019739  Bard¿ Urine Meter Foley Catheter Tray With Bardex¿ Lubricath¿ Foley Catheter REF: 902916 UDI codes: 00801741024863 10801741024860  (416A) SureStep Foley Tray System Bardex IC Complete Care (714A/716A/718A)SureStep Foley Tray System Bardex IC Complete REF: A304914 A304916 A304918 UDI codes:  00801741104350¿ 10801741104357 00801741104367¿ 10801741104364 00801741100499¿ 10801741100496  SureStep\" Foley Tray System Bard¿ Lubricath Foley REF: A800365 UDI codes: 00801741073960 10801741073967  SureStep\" Foley Tray System Bardex¿ Lubricath¿ Foley Catheter REF: A899918 UDI codes: 00801741074028 10801741074025  SureStep\" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902618 UDI codes: 00801741104640 10801741104647  SureStep\" Foley Tray System Bard¿Lubricath¿ Foley Catheter REF: A902616 UDI codes: 00801741104633¿ 10801741104630  SureStep Intermittent Catheter Tray REF: INTL16C UDI codes: 00801741183195¿ 10801741183192",
      "more_code_info": ""
    }
  ]
}