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.
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