FDAFDA · Food and drugs·Recall number Z-2784-2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M
Published July 29, 2026 · Recall initiated: June 8, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
- Lot
- CDS980523M UDI-DI 10195327508913 Lots 25KBJ177 25LBO527 26ABT761
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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