Recall Z-2508-2026
- Recall number
- Z-2508-2026
- Event number
- 98994
- Firm FEI
- 1417592
- Product code
- OJH
- Status
- Open, Classified
- Initiated
- 2026-05-04
- Posted
- 2026-06-17
- Root cause
- Nonconforming Material/Component
Product#
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.
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.