Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray
Medical device recall Z-3117-2026. 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
- 391720 units/kits 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: 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.
391720 units/kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SureStep Intermittent Catheter Tray INTP16 / 00801741183300¿ 10801741183307 Lot Numbers: NGKT3672 NGKU1467 NGKU3559 INTS14 / 00801741183218 10801741183215 Lot Numbers: NGKT2630 NGKT2687 NGKT3636 NGKT3673 NGKU0119 NGKU0134 NGKU1412 NGKU1439…
Every code shown here, 1,260 characters
SureStep Intermittent Catheter Tray INTP16 / 00801741183300¿ 10801741183307 Lot Numbers: NGKT3672 NGKU1467 NGKU3559 INTS14 / 00801741183218 10801741183215 Lot Numbers: NGKT2630 NGKT2687 NGKT3636 NGKT3673 NGKU0119 NGKU0134 NGKU1412 NGKU1439 NGKU1494 NGKU2451 NGKU2487 NGKU2510 INTS14C / 00801741183232 10801741183239 Lot Numbers: NGKT2660 NGKU0149 NGKU1468 INTS16 / 00801741183225 10801741183222 Lot Numbers: NGKT2688 NGKT3587 NGKU0135 NGKU2423 INTS16C / 00801741183249 10801741183246 Lot Numbers: NGKT2631 NGKU0120 NGKU1413 PEDINTS06 / 00801741183263¿ 10801741183260 Lot Number: NGKU2452 PEDINTS08 / 00801741183270 10801741183277 Lot Numbers: NGKT3637 NGKU0166 NGKU1495 PEDINTS10 / 00801741183287¿ 10801741183284 Lot Number: NGKT3674 Pre-amendment INTL14 / 00801741183164 10801741183161 Lot Numbers: NGKT3670 NGKU0132 NGKU1491 INTL15 / 00801741183171 10801741183178 Lot Numbers: NGKT2658 NGKT3584 NGKT3609 NGKU0116 NGKU0118 NGKU0133 NGKU0147 NGKU0163 NGKU1411 NGKU1436 NGKU1437 NGKU1465 NGKU1466 NGKU1492 NGKU2421 NGKU2449 NGKU2450 NGKU2485 NGKU2486 NGKU2508 NGKU2509 NGKU4598 NGKU4601 INTL16 / 00801741183188 10801741183185 Lot Number: NGKU3558 INTP14 / 00801741183294 10801741183291 Lot Numbers: NGKT2659 NGKT3585 NGKT3610 NGKT3635 NGKU0148 NGKU1438 NGKU3567
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.