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-2798-2026
- 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. HEART CATH, SELF REGIONAL SELF131-05
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 10809160408650 Lots 1618351 1621441 1627930 1635908 1644501 1646021 1651957 1654887 1656581 1656582 1659713 1670884 1670885 1671950
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-2798-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.