Class II U.S. Food and Drug Administration

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters 5cc recall: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters

Recall published 3 months ago

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

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: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

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-2784-2026
Published
July 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
980 kits
Distribution
Nationwide
Made in
United States
Lot / code info
CDS980523M UDI-DI 10195327508913 Lots 25KBJ177 25LBO527 26ABT761
UPC codes
10195327508913

Products covered by this recall

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M

Check your product

The notice names 1 code 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.

  • 10195327508913

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

Medline Industries, LP — 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: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

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 Medline Industries, LP medical devices recalled?

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10195327508913. 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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