Class II U.S. Food and Drug Administration

C.R. Bard Inc Products that contain the Pericare Wipes: SureStep" Foley Tray System 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-3118-2026
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
33850 units/kits
Distribution
Nationwide
Made in
United States
Lot / code info
SureStep" Foley Tray System Add-A-Foley Catheter A153200 / 00801741121067¿ 10801741121064 Lot Number: NGKS2397 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A304400A / 00801741073847¿ 10801741073844 Lot Numbers: NGKU1023 NGKU3043 SureStep" Foley Tray System Add-A-Foley Catheter A399400 / 00801741100369¿ 10801741100366 Lot Number: NGKU2042 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A399400A / 00801741073915¿ 10801741073912 Lot Numbers: NGKT2456 NGKT3292 NGKU0999 NGKU1026 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter A904400A / 00801741074097¿ 10801741074094 Lot Numbers: NGKT3231 NGKU2051 SureStep Intermittent Catheter Tray INTAAI / 00801741183317 10801741183314 Lot Number: NGKU1409
UPC codes
00801741121067, 10801741121064, 00801741073847, 10801741073844, 00801741100369, 10801741100366, 00801741073915, 10801741073912, 00801741074097, 10801741074094, 00801741183317, 10801741183314

Products covered by this recall

Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Catheter REF: A153200 UDI code: 00801741121067¿ 10801741121064 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A304400A UDI code: 00801741073847¿ 10801741073844 SureStep" Foley Tray System Add-A-Foley Catheter REF: A399400 UDI code: 00801741100369¿ 10801741100366 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A399400A UDI code: 00801741073915¿ 10801741073912 SureStep" Foley Tray System Complete Care¿ Add-A-Foley Catheter REF: A904400A UDI code: 00801741074097¿ 10801741074094 SureStep Intermittent Catheter Tray REF: INTAAI UDI code: 00801741183317 10801741183314 For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

Check your product

The notice names 17 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.

  • 00801741121067
  • 10801741121064
  • 00801741073847
  • 10801741073844
  • 00801741100369
  • 10801741100366
  • 00801741073915
  • 10801741073912
  • 00801741074097
  • 10801741074094
  • 00801741183317
  • 10801741183314

Lot or batch code

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

  • NGKS2397 SureStep
  • NGKU1023 NGKU3043 SureStep
  • NGKU2042 SureStep
  • 00801741
  • NGKU1409 — 33850 units

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. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

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 00801741121067, 10801741121064, 00801741073847; lot code NGKS2397 SureStep, NGKU1023 NGKU3043 SureStep, NGKU2042 SureStep. 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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