FDAFDA recall Z-2796-2026 · Aug 12, 2026
AVID Medical, Inc.: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall
Recall found
Product
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI 10809160377314 Lots 1573593 1583827 1609541 1612134 1612516 1619132 1623384 1627013 1635459 1672306 1675159
- Quantity
- 5168 kits
- Distribution
- US Nationwide distribution in the states of NC and TX.
- Recalling firm
- AVID Medical, Inc., Toano, VA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-04-30
Source: openFDA enforcement record Z-2796-2026 · search recall number Z-2796-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.