Recall Z-2479-2026
- Recall number
- Z-2479-2026
- Event number
- 98994
- Firm FEI
- 1417592
- Product code
- EYB
- Status
- Open, Classified
- Initiated
- 2026-05-04
- Posted
- 2026-06-17
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K092250, K033368, K921838, K043581, K930483, K180182, K191187, K941012, K182122, K950300, K020577, K021856, K183323, K933020, K923729, K941010, K962004, K032521, K914358, K030293, K192183, K941011, K133750, K882130, K171043, K083788, K964899, K182695
Product#
MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.
Reason for Recall#
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.