Products that contain the Pericare Wipes: *Bardex¿ I.C
Medical device recall Z-3116-2026. 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
- 212580 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: *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.
212580, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Bardex¿ I.C. Complete Care¿ Foley Catheter Tray 300316A / 00801741024344¿ 10801741024341 Lot Number: NGKT3657 Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter 303314A / 00801741024252¿ 10801741024259 Lot Number: NGKU4153…
Every code shown here, 1,999 characters
Bardex¿ I.C. Complete Care¿ Foley Catheter Tray 300316A / 00801741024344¿ 10801741024341 Lot Number: NGKT3657 Bardex¿ I.C. Complete Care¿ Foley Catheter Tray and Urine Meter 303314A / 00801741024252¿ 10801741024259 Lot Number: NGKU4153 303316A / 00801741024269 10801741024266 Lot Number: NGKW2883 303318A / 00801741024276¿ 10801741024273 Lot Number: NGKU0966 *SureStep” Foley Tray System Bardex¿ IC Complete Care¿ A300314A / 00801741073724¿ 10801741073721 Lot Number: NGKU1020 A300314AC (Canada Only) / 00801741143243 Lot Number: **** SureStep” Foley Tray System Bardex¿ IC Complete Care¿ A300316A / 00801741073731 10801741073738 Lot Numbers: NGKT2448 NGKT3221 NGKT3288 NGKT3301 NGKT3315 NGKU2921 NGKV0293 SureStep” Foley Tray System Bardex¿ IC Complete Care¿ A300318A / 00801741073748¿ 10801741073745 Lot Number: NGKT2493 SureStep” Foley Tray System Bardex¿ IC Complete Care¿ A303314A / 00801741073786¿ 10801741073783 Lot Numbers: NGKT3222 NGKV0249 A303316A / 00801741073793¿ 10801741073790 Lot Numbers: NGKU0894 NGKU0947 NGKU0973 NGKU1021 NGKU1748 NGKU1826 NGKU1830 NGKU2034 NGKU2035 NGKU2996 NGKU3042 NGKU3969 NGKU4037 NGKU4077 NGKU4078 NGKU4135 NGKU4713 NGKU4714 NGKU4720 NGKU4721 NGKU4722 NGKU4727 NGKV2390 NGKV3390 A303318A / 00801741073809¿ 10801741073806 Lot Numbers: NGKT3223 NGKU4136 SureStep” Foley Tray System Lubri-Sil¿ IC Complete Care¿ A303414A / 00801741073816¿ 10801741073813 Lot Number: NGKU1022 (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 A304716A / 00801741104206 10801741104203 Lot Number: NGKT2496 A304714A / 00801741104268 10801741104265 Lot Number: NGKU2923 A304716A / 00801741104299 10801741104296 Lot Numbers: NGKU1833 NGKU4729 A304718A / 00801741100376¿ 10801741100373 Lot Numbers: NGKT3224 NGKU3971 SureStep” Foley Tray System Bardex¿ IC Complete Care¿ A319416A / 00801741100307¿ 10801741100304 Lot Number: NGKS1605 SureStep” Foley Tray System Bardex¿…
FDA’s list runs to 2,890 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 2,890 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.