Recall Z-2502-2026
- Recall number
- Z-2502-2026
- Event number
- 98994
- Firm FEI
- 1417592
- Product code
- M
- Status
- Open, Classified
- Initiated
- 2026-05-04
- Posted
- 2026-06-17
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K931822
Product#
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
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.