The Recall Desk
HighFDA (Devices)·Z-2782-2026·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 potential hazard where the excess material 'ay be harmful,' 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 affected kits are identified by code DYNJT6105 and UDI-DI 10198459539381, specifically lots 25JBM474 and 25LBS203.

The manufacturer initiated this recall because an increased amount of raw material was found on the surface of the catheters. This issue may cause the catheters to exhibit staining on the surface, and the excess raw material may be harmful to users.

These kits were distributed nationwide in the states of CA, FL, MD, PA, and TX. Users should check their inventory for the affected lot numbers.

The recalled product

Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105
Manufacturer
Medline Industries, LP
Category
Medical Device — Urinary Catheters
Hazard
  • material-contamination
  • harmful-substance

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)

  • DYNJT6105 UDI-DI 10198459539381 Lots 25JBM474 25LBS203

Distribution

Distributed nationwide across the United States.

Related recalls

Same category