Recall
FDAHealthJune 8, 2026

Medline Industries, LP — Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U

⚠️ 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. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
Lot code
25IMC004

Additional details

DYNJ0945779U UDI-DI 10195327632656 Lots 25IMC004 25JMD942 25JMJ441 25LMG068

What should I do?

Recommended action

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

View original FDA notice →

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