Official recall notice

FDA DeviceClass IINotable

FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba

Recall date
2026-07-29
FDA class
Class II

Why it was recalled

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.

Product description

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.

Affected products

DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710

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