Medical Device Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M
Medline Industries, LP · June 8, 2026
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of CA, FL, MD. PA, and TX.
States Affected
NATIONWIDE
Quantity Affected
980 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2784-2026
Status: ongoing
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