Recall
FDAHealthJune 8, 2026

Medline Industries, LP — Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 8, 2026

US Nationwide distribution in the states of CA, FL, MD. PA, and TX.

What's affected?

Product
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Lot code
25GBG086

Additional details

DYKMBNDL116G UDI-DI 10198459156991 Lots 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 980 kits.

View original FDA notice →

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