Recall Z-2797-2026
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. SAMMC ANGIOGRAPHY SAMM066-15
Codes / lots: UDI-DI 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932
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-2797-2026
- Initiated
- April 30, 2026
- Posted by FDA
- July 31, 2026
- Product code
- OES – Cardiac Catheterization 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-2798-2026 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 |