Class II U.S. Food and Drug Administration

C.R. Bard Inc Products that contain the Pericare Wipes: SureStep Intermittent recall: Due to complaints received indicating presence of contamination

Recall published last month

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3117-2026
Published
September 16, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
C.R. Bard Inc
Product type
Medical devices
Units affected
391720 units/kits
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00801741183300, 10801741183307, 00801741183218, 10801741183215, 00801741183232, 10801741183239, 00801741183225, 10801741183222, 00801741183249, 10801741183246, 00801741183263, 10801741183260, 00801741183270, 10801741183277, 00801741183287, 10801741183284, 00801741183164, 10801741183161, 00801741183171, 10801741183178

Products covered by this recall

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.

Check your product

The notice names 30 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00801741183300
  • 10801741183307
  • 00801741183218
  • 10801741183215
  • 00801741183232
  • 10801741183239
  • 00801741183225
  • 10801741183222
  • 00801741183249
  • 10801741183246
  • 00801741183263
  • 10801741183260
  • 00801741183270
  • 10801741183277
  • 00801741183287
  • 10801741183284
  • 00801741183164
  • 10801741183161
  • 00801741183171
  • 10801741183178

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • NGKT3672 NGKU1467 NGKU3559 INTS14
  • 00801741183218 10801741183215 Lot N
  • NGKT2660 NGKU0149 NGKU1468 INTS16
  • 00801741183225 10801741183222 Lot N
  • NGKT2631 NGKU0120 NGKU1413 PEDINTS06
  • 00801741183263
  • NGKU2452 PEDINTS08
  • NGKT3674 Pre-amendment INTL14
  • 00801741183164 10801741183161 Lot Numbe
  • NGKU3558 INTP14

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

C.R. Bard Inc — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: C.R. Bard Inc — 8195 Industrial Blvd Ne, Covington, GA, 30014-1497

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was C.R. Bard Inc medical devices recalled?

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00801741183300, 10801741183307, 00801741183218; lot code NGKT3672 NGKU1467 NGKU3559 INTS14, 00801741183218 10801741183215 Lot N, NGKT2660 NGKU0149 NGKU1468 INTS16. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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