FDA Medical devices recall ·

Halyard convenience kits containing recalled Medline Namic Angiographic… recall

This is an FDA Class I recall — the most serious type.

Recall number
Z-2796-2026
Date
(initiated April 30, 2026)
Company / brand
AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States
Category
Medical devices › Class I
Classification
Class I
Status
Ongoing
Units affected
5168 kits
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI-DI 10809160377314 Lots 1573593 1583827 1609541 1612134 1612516 1619132 1623384 1627013 1635459 1672306 1675159

Distribution

US Nationwide distribution in the states of NC and TX.

States: North Carolina Texas

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-2796-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.