The Recall Desk
HighFDA (Devices)·Z-2779-2026·Announced 2026-07-29

Medline Bard Silastic Foley Catheter Kits Recalled Due to Surface Contamination

Medline is recalling 980 Bard Silastic Foley Catheter kits due to increased raw material on the catheter surface that may be harmful.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall for a risk-of-harm product where injury has not yet been reported. The increased raw material on the catheter surface may be harmful but no illnesses or injuries have been documented.

Plain-English summary

Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. The kits were recalled because the catheters have an increased amount of raw material on the surface, which may result in staining and could be harmful to users. The affected kits were distributed nationwide in California, Florida, Maryland, Pennsylvania, and Texas. Consumers should stop using the affected products and contact Medline for a replacement.

The recalled product

Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I
Manufacturer
Medline Industries, LP
Category
Medical Device — Urinary catheter
Hazard
  • contamination
  • staining

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710

Distribution

Distributed nationwide across the United States.

Related recalls

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