Recall Z-2779-2026— Medline Industries, LP
Class II · Ongoing
Class II FDA medical device recall by Medline Industries, LP, initiated 2026-06-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I. Reason: 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..
- Recalling firm
- Medline Industries, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-08
- Firm location
- Northfield, IL, United States
Product description
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.