Open, Classified

Products that contain the Pericare Wipes: Bardex I.C. Complete Care Foley Catheter Tray REF: 300316A UDI codes: 00801741024344 10801741024341 Bardex I.C. Complete Care Foley Catheter Tray and Urine Meter REF: 303314A 303316A 303318A UDI code: 00801741024252 10801741024259 00801741024269 10801741024266 00801741024276 10801741024273 SureStep" Foley Tray System Bardex IC Complete Care REF: A300314A UDI codes: 00801741073724 10801741073721 REF: A300314AC (Canada Only) UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex IC Complete Care REF: A300316A UDI code: 00801741073731 10801741073738 SureStep" Foley Tray System Bardex IC Complete Care REF: A300318A UDI code: 00801741073748 10801741073745 SureStep" Foley Tray System Bardex IC Complete Care REF: A303314A A303316A A303318A UDI code: 00801741073786 10801741073783 00801741073793 10801741073790 00801741073809 10801741073806 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A303414A UDI code: 00801741073816 10801741073813 (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 10801741104203 00801741104268 10801741104265 00801741104299 10801741104296 00801741100376 10801741100373 SureStep" Foley Tray System Bardex IC Complete Care REF: A319416A UDI code: 00801741100307 10801741100304 SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319416AM UDI code: 00801741073861 10801741073868 *SureStep" Foley Tray System Bardex IC Complete Care REF: A319418A UDI code: 00801741100314 10801741100311 SureStep" Foley Tray System Bardex IC Complete Care REF: A903316A UDI code: 00801741096600 10801741096607 ***** SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300414A UDI code: 00801741073755 10801741073752 SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319414AM UDI code: 00801741073854 10801741073851 SureStep" Foley Tray System Bardex I.C. Complete Care Foley Catheter REF: A319418AM UDI code: 00801741073878 10801741073875 SureStep" Foley Tray System Bardex IC Complete Care REF: A903318A UDI code: 00801741104657 10801741104654 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

FDA Recall Z-3116-2026 · Posted 2026-09-04

Recall StatusOpen, Classified

Product CodeMJC

Date Initiated2026-06-25

Product Quantity212580

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.

Firm Action

On 06/25/2026, an "URGENT Medical Device Recall" Letter was via regional courier services or other electronic means to inform customers that based on customer feedback, BD has identified that the CliniClean Pericare Wipes provided within Urinary Catheter Trays may be potentially contaminated with an unknown non-biological substance. Customer are instructed to: Do not use CliniClean Pericare Wipes contained within the affected products listed in Attachment 2. The CliniClean Pericare Wipes are the only impacted component within the tray and all remaining components can continue to be safely used. Users should source alternative, cleansing wipes for the impacted product lots listed in Attachment 2 and ensure they continue to follow their facility protocols for providing perineal care for patients with urinary catheters. If affected CliniClean Pericare Wipes have been used without issue, no additional treatment or clinical follow up is required. 1. For affected lots, remove and destroy wipes within the product package at the point of use and do not use. Source alternative cleansing wipes for all impacted urinary catheter trays listed in Attachment 2. 2. Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Correction. 3. Post this notice in all locations where inventory of these trays are stored. 4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may confirm your receipt of this notification. For Questions - contact: BD Medical Information Services: Available 24/7 Select #2 when prompted 1-800-555-7422 or Email: [email protected] BD Technical Support 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaint when prompted M-F 8am - 5pm CT or Email: [email protected]

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040658BARDEX I.C. LATEX FOLEY CATHETERC.R. Bard, Inc. · 2004-09-29 K984136BARDEX LUBRI-SIL I.C. FOLEY CATHETERBard Medical Div. · 1999-02-16 K910318BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETERC.R. Bard, Inc. · 1994-08-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.