FDA Device recall Z-2148-2026
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
- FDA Device
- Class I
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class I recall of Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C by Medline Industries, citing medline has identified the presence of particulate within the fluid path of the Manifolds.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2148-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-03-24 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C
Reason
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Identifiers
| code_info | UDI/DI each 10193489475135, UDI/DI case 40193489475136, Lot Numbers: 23GBR742, 23IBC951, 23JBM554, 23LBK506, 24BBO670, 24GBM624. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2148-2026%22
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