Z-2797-2026Class I

Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC...

Name: Z-2797-2026 Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC...
Creator: AVID Medical, Inc.
Published: 2026-04-30
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2026-04-30 / Open, Classified / root cause: manufacturing process

FDA source

AVID Medical, Inc. began a recall of Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15 on 2026-04-30. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2797-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-04-30
Posted: 2026-07-31
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Product code: OES Cardiac Catheterization Kit
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 5168 kits
Distribution: US Nationwide distribution in the states of NC and TX.
Product codes and lots: UDI-DI 10809160388495 Lots 1561685 1575926 1583048 1584017 1589652 1595715 1599634 1605749 1611810 1621476 1637222 1637224 1637225 1643118 1645143 1645637 1663929 1663930 1663931 1663932

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2797-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2796-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31
Z-2797-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31
Z-2798-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-07-31

Product code OES

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)