Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP16 INTS14 INTS14C INTS16 INTS16C PEDINTS06 PEDINTS08 PEDINTS10 UDI code: 00801741183300 10801741183307 00801741183218 10801741183215 00801741183232 10801741183239 00801741183225 10801741183222 00801741183249 10801741183246 00801741183263 10801741183260 00801741183270 10801741183277 00801741183287 10801741183284 Preamendment REF: INTL14 INTL15 INTL16 INTP14 UDI code: 00801741183164 10801741183161 00801741183171 10801741183178 00801741183188 10801741183185 00801741183294 10801741183291 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

FDA Recall Z-3117-2026 · Posted 2026-09-04

Recalling FirmC.R. Bard Inc
Recall StatusOpen, Classified
Product CodeKOD
Date Initiated2026-06-25
Product Quantity391720 units/kits

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.

Official Source

View FDA Recall →

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

↑