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RecallWatchMedical Device Safety
Class IIOngoingZ-3116-2026

C.R. Bard Inc recalls Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter…

C.R. Bard IncCovington, GA, United StatesReported Sep 16, 2026 · 6 days ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    117 affected lots
    NGKT3657303314A10801741024259NGKU4153303316A0080174102426910801741024266NGKW2883
    +109 more303318A10801741024273NGKU0966A300314A10801741073721NGKU1020A300314AC00801741143243A300316A0080174107373110801741073738NGKT2448NGKT3221NGKT3288NGKT3301NGKT3315NGKU2921NGKV0293A300318A10801741073745NGKT2493A303314A10801741073783NGKT3222NGKV0249A303316A10801741073790NGKU0894NGKU0947NGKU0973NGKU1021NGKU1748NGKU1826NGKU1830NGKU2034NGKU2035NGKU2996NGKU3042NGKU3969NGKU4037NGKU4077NGKU4078NGKU4135NGKU4713NGKU4714NGKU4720NGKU4721NGKU4722NGKU4727NGKV2390NGKV3390A303318A10801741073806NGKT3223NGKU4136A303414A10801741073813NGKU1022A304716A0080174110420610801741104203NGKT2496A304714A0080174110426810801741104265NGKU2923A304716A0080174110429910801741104296NGKU1833NGKU4729A304718A10801741100373NGKT3224NGKU3971A319416A10801741100304NGKS1605A319416AM10801741073868NGKT2390NGKT2410NGKT3225NGKT3319NGKU0951NGKU0977A319418A10801741100311NGKT2411A903316A10801741096607NGKT3392NGKU2020A300414A0080174107375510801741073752NGKV3524A319414AM0080174107385410801741073851NGKV3487A319418AM0080174107387810801741073875NGKV4983A903318A0080174110465710801741104654NGKV2397

What the firm is doing

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

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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