Class II U.S. Food and Drug Administration

C.R. Bard Inc Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 recall: Due to stain present on the surface of affected foley catheters

Recall published 5 months ago

Due to stain present on the surface of affected foley catheters.

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 stain present on the surface of affected foley catheters.

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-2226-2026
Published
May 27, 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
106,160
Distribution
Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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
Made in
United States
Lot / code info
Silastic Brand Foley Catheter 30cc Catalog Number / UDI code: 33416 / 00801741019982 10801741019989 Lot Number: NGKX0444 33418 / 00801741019999 10801741019996 Lot Number: NGKW2813 33420 / 00801741020001 10801741020008 Lot Number: NGKQ1015 33422 / 00801741020018 10801741020015 Lot Number: NGKW3707 33424 / 00801741020025 10801741020022 Lot Number: NGKW2669 Silastic Brand Foley Catheter 5cc Catalog Number / UDI code: 33614 / 00801741020056 10801741020053 Lot Numbers: NGKN4037 NGKP1420 NGKQ0040 NGKQ3901 NGKS4937 NGKV3462 NGKW3897 33616 / 00801741020063 10801741020060 Lot Numbers: NGKQ0042 NGKQ3946 NGKR3420 NGKT3281 NGKU1015 NGKV0617 NGKV2275 NGKV2309 NGKW3771 33618 / 00801741020070 10801741020077 Lot Numbers: NGKQ3370 NGKS3753 NGKT3258 NGKT3309 NGKU4129 NGKV1446 NGKV2345 NGKV3478 NGKV5029 33620 / 00801741020087 10801741020084 Lot Numbers: NGKS5060 NGKT3308 NGKV3689 33622 / 00801741020094 10801741020091 Lot Numbers: NGKQ1016 NGKS0244 NGKU0967 NGKV5075 NGKX0441 33624 / 00801741020100 10801741020107 Lot Numbers: NGKQ1722 NGKQ3862 NGKT3259 NGKX0456
UPC codes
00801741019982, 10801741019989, 00801741019999, 10801741019996, 00801741020001, 10801741020008, 00801741020018, 10801741020015, 00801741020025, 10801741020022, 00801741020056, 10801741020053, 00801741020063, 10801741020060, 00801741020070, 10801741020077, 00801741020087, 10801741020084, 00801741020094, 10801741020091

Products covered by this recall

Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624

Check your product

The notice names 25 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.

  • 00801741019982
  • 10801741019989
  • 00801741019999
  • 10801741019996
  • 00801741020001
  • 10801741020008
  • 00801741020018
  • 10801741020015
  • 00801741020025
  • 10801741020022
  • 00801741020056
  • 10801741020053
  • 00801741020063
  • 10801741020060
  • 00801741020070
  • 10801741020077
  • 00801741020087
  • 10801741020084
  • 00801741020094
  • 10801741020091

Lot or batch code

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

  • NGKX0444 33418
  • NGKQ1015 33422
  • NGKS5060 NGKT3308 NGKV3689 33622
  • 00801741020094 10801741020091 Lot Nu
  • 160

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. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

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 stain present on the surface of affected foley catheters. Due to stain present on the surface of affected foley catheters.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00801741019982, 10801741019989, 00801741019999; lot code NGKX0444 33418, NGKQ1015 33422, NGKS5060 NGKT3308 NGKV3689 33622. 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.

Which states were affected?

The notice lists Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois and others.

Related recalls