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-2797-2026
- 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. SAMMC ANGIOGRAPHY SAMM066-15
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 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932
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-2797-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.