FDAHealthJune 8, 2026
Medline Industries, LP — Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M
⚠️ 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. ROBOTIC CDS980523M
- Lot code
- 25KBJ177
Additional details
CDS980523M UDI-DI 10195327508913 Lots 25KBJ177 25LBO527 26ABT761
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 980 kits.
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