Recall Z-2781-2026
- Recall number
- Z-2781-2026
- Event number
- 99301
- Firm
- Medline Industries, LP
- Firm FEI
- 1417592
- Product code
- LRO
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-07-23
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K905459, K920267, K934028, K883250, K871322, K212258, K874760, K892389, K872011, K934688, K882684, K941846, K920292, K932652, K945831, K901856, K931824, K873973, K933137, K925216, K945481, K961683, K953083, K935686, K854292, K971062, K930270, K914037, K935740, K980137
Product#
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
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.