Halyard convenience kits containing recalled Medline Namic… recallZ-2797-2026 · AVID Medical, Inc. · initiated Apr 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AVID Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
On April 30, 2026, firm notified distributors via email. Distributors were tasked with notifying their end-users. Customers were instructed to identify, segregate, and quarantine all impacted products. They were provided with a labeling template to print warning labels which should be affixed on all affected kits and cases in inventory. The firm is also able to provide pre-printed labels if needed. Warning labels inform users to remove and discard the manifold prior to use.
Recall details
- Recall number
- Z-2797-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 30, 2026
- Posted by the FDA
- Jul 31, 2026
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 5168 kits
- Product code
- OES
- Distribution
- US Nationwide distribution in the states of NC and TX.
Product description
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Code information (models, lots, serial 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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard SAMM066-15_0017Avid Medical, Inc. · Cardiac catheterization kit3 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99339).
- Z-2796-2026 · Open, ClassifiedHalyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05
- Z-2798-2026 · Open, ClassifiedHalyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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