FDA Device recall Z-2798-2026
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds
- FDA Device
- Class I
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class I recall of Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds by Avid Medical, citing affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2798-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-04-30 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Reason
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Identifiers
| code_info | UDI-DI 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950 |
|---|
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-2798-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.