The Recall Desk
HighFDA (Devices)·Z-2783-2026·Announced 2026-07-29

Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface 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: The product is a medical device with a high-risk hazard (potential harm from raw material) where injury has not yet been reported, and it is classified as FDA Class II.

Plain-English summary

Medline Industries, LP is recalling Medline convenience kits that contain Bard Silastic Foley Catheters (French sizes 16, 18, 20) with 5cc balloons. The recall is due to an increased amount of raw material present on the surface of the catheters.

This issue may cause the catheters to exhibit staining on the surface. The presence of increased amounts of raw material on the catheter surface may be harmful to users.

This recall affects 980 kits distributed nationwide in California, Florida, Maryland, Pennsylvania, and Texas. The affected lots include 25KBA955 and 26CBL889.

The recalled product

Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B
Manufacturer
Medline Industries, LP
Category
Medical Device — Urinary Catheters
Hazard
  • material-contamination

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)

  • DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889

Distribution

Distributed nationwide across the United States.

Related recalls

Same category