Recall Z-2496-2026
- Recall number
- Z-2496-2026
- Event number
- 98994
- Firm FEI
- 1417592
- Product code
- KDD
- Status
- Open, Classified
- Initiated
- 2026-05-04
- Posted
- 2026-06-17
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K821814, K803119, K902441, K925905, K780336, K072814, K920989, K911606, K813103, K811086, K910366, K920516, K843115, K910369, K920763, K924117, K880785, K802017, K803118, K821501, K960456, K780488, K832047, K864969, K870373, K871458, K760051, K831841, K832628, K802557
Product#
MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.
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.