Recall archive / FDA device enforcement
Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 0... — FDA record Z-3114-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 25, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: 899914 899916 899918 UDI codes: 00801741024801¿ 10801741024808 00801741024818¿ 10801741024815 00801741024825¿ 10801741024822 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 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
- Reason
- Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Classification
- Class II
- Recalling firm
- C.R. Bard Inc
- Quantity
- 12,463 trays/kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3114-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 16, 2026
- Recall initiation date
- Jun 25, 2026
- Center classification date
- Sep 4, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.