FDA Medical devices recall ·
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿… recall
- Recall number
- Z-3115-2026
- Date
- (initiated June 25, 2026)
- Company / brand
- C.R. Bard Inc
8195 Industrial Blvd Ne, Covington, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 283883 trays/kits
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924¿ 10801741024921 00801741024931¿ 10801741024938 00801741024948¿ 10801741024945 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray REF: 300416A UDI code: 00801741024580 10801741024587 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A300416A UDI code: 00801741073762¿ 10801741073769 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A303416A UDI code: 00801741073823 10801741073820 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A307416A A307418A UDI codes: 00801741104381¿ 10801741104388 00801741100505¿ 10801741100502 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897516 UDI code: 00801741073984 10801741073981 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray REF: A902416 UDI code: 00801741074042¿ 10801741074049 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray REF: A902418 UDI code: 00801741074059¿ 10801741074056 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter REF: A907316 UDI code: 00801741104749¿ 10801741104746 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942210 UDI code: 00801741100567¿ 10801741100564 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942212 UDI code: 00801741100536¿ 10801741100533 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942214 UDI code: 00801741074103¿ 10801741074100 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942216 UDI code: 00801741074110 10801741074117 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter REF: A947316 UDI code: 00801741074141 10801741074148 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942206 UDI code: 00801741100543 10801741100540 **** Lubri-Sil¿ I.C. Complete Care¿ Temp-Sensing Foley Catheter Tray and Urine Meter REF: 319516AM UDI code: 00801741024696¿ 10801741024693 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter REF: A119214M UDI code: 00801741073670¿ 10801741073677 REF: A119216M UDI code: 00801741073687 10801741073684 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter REF: A300916A UDI code: 00801741120862¿ 10801741120869 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516A UDI code: 00801741100338 10801741100335 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516AM UDI code: 00801741073892 10801741073899 SureStep" Foley Tray Lubri-Sil¿ I.C. Complete Care¿ Temp Sensing Catheter REF: A900916A UDI code: 00801741121029¿ 10801741121026 SureStep" Foley Tray System Lubri-Sil¿ Temperature Sensing Foley Catheter REF: A909216M UDI code: 00801741104763¿ 10801741104760 ***** Bard¿ Urine Meter Foley Catheter Tray With Bard¿ Lubri-Sil¿ Catheter REF 942208 UDI code: 00801741029370 10801741029377 Bard¿ Urine Meter Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter REF: 942216 UDI code: 00801741024979 10801741024976 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray and Urine Meter REF: 303416A UDI code: 00801741024726 10801741024723 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Temp Sensing Foley Catheter REF: A119218M UDI code: 00801741073694 10801741073691 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A300418A UDI code: 00801741073779 10801741073776 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A303418A UDI code: 00801741073830 10801741073837 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319514AM UDI code: 00801741073885 10801741073882 SureStep" Foley Tray System with Bard¿ Lubri-Sil¿ Catheter REF: A942208 UDI code: 00801741100550 10801741100557 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley Catheter Tray REF: A942218 UDI code: 00801741074127 10801741074124 SureStep" Foley Tray System Bard¿ Lubri-Sil¿ Foley
Why was it recalled?
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone Foley Catheter Catalog Numbers / UDI codes: 947314 / 00801741024924¿ 10801741024921 Lot Numbers: NGKT2599 NGKU0115 947316 / 00801741024931¿ 10801741024938 Lot Numbers: NGKU0162 NGKU2507 947318 / 00801741024948¿ 10801741024945 Lot Numbers: NGKU2420 NGKU2865 Lubri-Sil¿ I.C. Complete Care¿ All-Silicone Foley Catheter Tray 300416A / 00801741024580 10801741024587 Lot Numbers: NGKT1464 NGKU0129 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A300416A / 00801741073762¿ 10801741073769 Lot Numbers: NGKT3316 NGKU0946 NGKU0972 NGKU1747 NGKU1823 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A303416A / 00801741073823 10801741073820 Lot Numbers: NGKT2388 NGKT2495 NGKT3290 NGKT3303 NGKT3318 NGKU0949 NGKU0974 NGKU1749 NGKU2011 NGKU2036 NGKU2922 NGKV0359 NGKV0360 NGKV1433 NGKV1454 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A307416A / 00801741104381 10801741104388 Lot Number: NGKS3764 A307418A / 00801741100505 10801741100502 Lot Number: NGKT2453 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897516 / 00801741073984 10801741073981 Lot Numbers: NGKT3226 NGKU0841 NGKU0954 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray A902416 / 00801741074042¿ 10801741074049 Lot Numbers: NGKU0843 NGKU2016 NGKU2049 NGKU2887 NGKU2929 NGKU3049 NGKU3975 NGKU4043 NGKU4716 SureStep" Foley Tray System Bardex¿ All- Silicone Foley Catheter Tray A902418 / 00801741074059¿ 10801741074056 Lot Number: NGKU0956
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: 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 Washington Wisconsin Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3115-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.