Recall
FDAHealthJune 8, 2026

Medline Industries, LP — Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B

⚠️ 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. PROSTATE ROBOTIC DYNJ901822B
Lot code
25KBA955

Additional details

DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889

What should I do?

Recommended action

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

View original FDA notice →

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