Recall Z-2798-2026
AVID Medical, Inc. · initiated April 30, 2026
Class I – dangerous or defective products that could cause serious health problems or death
Product
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Codes / lots: UDI-DI 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
On April 30, 2026, firm notified distributors via email. Distributors were tasked with notifying their end-users. Customers were instructed to identify, segregate, and quarantine all impacted products. They were provided with a labeling template to print warning labels which should be affixed on all affected kits and cases in inventory. The firm is also able to provide pre-printed labels if needed. Warning labels inform users to remove and discard the manifold prior to use.
Details
- Recall number
- Z-2798-2026
- Initiated
- April 30, 2026
- Posted by FDA
- July 31, 2026
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 5168 kits
- Distribution
- US Nationwide distribution in the states of NC and TX.
- Recalling firm
- AVID Medical, Inc., Toano, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2796-2026 Class I | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the… | 04/30/2026Open, Classified |
| Z-2797-2026 Class I | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the… | 04/30/2026Open, Classified |