This is part of a larger recall. The most authoritative record is FDA-Device / Z-3116-2026.
FDA-Device2026-09-16Class IIPROCESSING DEFECT
C.R. Bard SureStep Foley and Intermittent Catheter Trays recalled for contaminated Pericare Wipes
What this means
C.R. Bard has recalled multiple SureStep Foley and Intermittent Catheter Tray kits because the Pericare Wipes included in these products may have contamination on their surface. The contamination was identified after customer complaints were received. No injuries have been reported.
- Check your SureStep catheter tray kit against the affected lot numbers listed in the recall notice.
- Do not use the Pericare Wipes from affected kits.
- Contact C.R. Bard or your healthcare provider for instructions on returning the product or obtaining a replacement.
The agency's original wording
Hazard
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
33850 units/kits
Manufactured in
8195 Industrial Blvd Ne, Covington, GA, United States
Products
Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369¿ 10801741100366 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915¿ 10801741073912 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097¿ 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3118-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.