FDA Device recall Z-2797-2026
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-2797-2026 |
| 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. SAMMC ANGIOGRAPHY SAMM066-15
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 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 163…UDI-DI 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932 |
|---|
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-2797-2026%22
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