Class 2 Device Recall Bard Foley/SureStep Foley Trays

• Date Initiated by Firm: June 25, 2026
• Date Posted: September 04, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3119-2026
• Recall Event ID: 98840
• Product Classification: Collector, Urine, (And Accessories) For Indwelling Catheter - Product Code KNX
• Product: Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex IC Complete Care REF: A300314AC UDI-DI code: 00801741143243 SureStep" Foley Tray System Bardex IC Complete Care REF: A300316AC UDI-DI code: 00801741143250 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319516AMC UDI-DI code: 00801741143472 SureStep" Foley Tray System Bard Lubricath Foley REF: A800366C UDI-DI code: 00801741143571 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A897514C UDI-DI code: 00801741074011 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A897516C UDI-DI code: 00801741143595 SureStep" Foley Tray System Bard Silicone Foley Catheter Tray REF: A902114C UDI-DI code: 00801741144325 ***** SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A300416AC UDI code: 00801741143281 10801741143288 SureStep" Foley Tray System Bardex IC Complete Care REF: A303314AC UDI code: 00801741143304 10801741143301 SureStep" Foley Tray System Lubri-Sil IC Complete Care REF: A319514AMC UDI code: 00801741143465 10801741143462 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800061C UDI code: 00801741144172 10801741144179 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800065C UDI code: 00801741144202 10801741144209 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800360C UDI code: 00801741143519 10801741143516 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF:A800361C UDI code: 00801741143526 10801741143523 SureStep" Foley Tray System Bard Lubricath Foley Catheter Tray REF: A800362C UDI code: 00801741143540 10801741143547 SureStep" Foley Tray System Bard Lubricath Foley REF: A800365C UDI code: 00801741143564 10801741143561 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.
• Code Information: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243 Lot Number: NGKT2492 SureStep" Foley Tray System Bardex¿ IC Complete Care¿ A300316AC / 00801741143250 Lot Number: NGKU2005 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ A319516AMC / 00801741143472 Lot Number: NGKT2392 SureStep" Foley Tray System Bard¿ Lubricath Foley A800366C / 00801741143571 Lot Number: NGKT2413 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897514C / 00801741074011¿ Lot Number: NGKU0852 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A897516C / 00801741143595 Lot Number: NGKT2393 SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray A902114C / 00801741144325 Lot Number: NGKU0854 **** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A300416AC / 00801741143281 10801741143288 Lot Number: NGKX2635 SureStep" Foley Tray System Bardex¿ IC Complete Care A303314AC / 00801741143304 10801741143301 Lot Number: NGKW2895 SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care A319514AMC / 00801741143465 10801741143462 Lot Number: NGKV2284 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800061C / 00801741144172 10801741144179 Lot Number: NGKV1388 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800065C / 00801741144202 10801741144209 Lot Number: NGKW1905 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800360C / 00801741143519 10801741143516 Lot Number: NGKV5086 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800361C / 00801741143526 10801741143523 Lot Number: NGKX4683 SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray A800362C / 00801741143540 10801741143547 Lot Number: NGKW2771 SureStep" Foley Tray System Bard¿ Lubricath Foley A800365C / 00801741143564 10801741143561 Lot Number: NGKW1853
• FEI Number: 1018233
• Recalling Firm/ Manufacturer: C.R. Bard Inc; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: 770-784-6100
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by 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: medical.information@bd.com BD Technical Support 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaint when prompted M-F 8am - 5pm CT or Email: productcomplaints@bd.com
• Quantity in Commerce: 364
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.