Products that contain the Pericare Wipes: (Canada Only) SureStep” Foley Tray System Bardex¿ IC Complete Care¿
Medical device recall Z-3119-2026. Published in FDA’s Enforcement Report on Sep 16, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 16, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 48 states named
- 364 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
364, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
(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…
Every code shown here, 1,874 characters
(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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
48 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 25, 2026.
- FDA classified it on Sep 4, 2026.
- FDA’s Enforcement Report published it on Sep 16, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- C.R. Bard Inc, of Covington, GA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.