FDA recall, , High risk
Halyard Cardiac Catheterization and Angiography Kits
Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Summary by Recall Canary from the FDA notice
What happened
AVID Medical, Inc. of Toano, Virginia recalled Halyard convenience kits containing Medline Namic Angiographic Star Off Handle Manifolds because the manifolds were recalled by the manufacturer due to presence of particulates within the fluid path. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
The recall began April 30, 2026, and was added to the FDA's Enforcement Report on July 31, 2026. The kits were distributed in the states of North Carolina and Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
3 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. Sammc Angiography SAMM066-15
- UDI-DI
- 10809160388495
- Lot code
- 1561685
- 1575926
- 1583048
- 1584017
- 1589652
- 1595715
- 1599634
- 1605749
- 1611810
- 1621476
- 1637222
- 1637224
- 1637225
- 1643118
- 1645143
- 1645637
- 1663929
- 1663930
- 1663931
- 1663932
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. Cardiac Cath Pack EAMC1000-05
- UDI-DI
- 10809160377314
- Lot code
- 1573593
- 1583827
- 1609541
- 1612134
- 1612516
- 1619132
- 1623384
- 1627013
- 1635459
- 1672306
- 1675159
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. Heart Cath, Self Regional SELF131-05
- UDI-DI
- 10809160408650
- Lot code
- 1618351
- 1621441
- 1627930
- 1635908
- 1644501
- 1646021
- 1651957
- 1654887
- 1656581
- 1656582
- 1659713
- 1670884
- 1670885
- 1671950
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of North Carolina and Texas.
- Company
- AVID Medical, Inc.Toano, Virginia
- Hazard
- Foreign object
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99339
- Recall numbers
- Z-2796-2026 to Z-2798-2026
All recalls from AVID Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
