Z-2792-2026Class I

Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle...

Name: Z-2792-2026 Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle...
Creator: Medical Action Industries, Inc. 306
Published: 2026-05-13
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2026-05-13 / Open, Classified / root cause: manufacturing process

FDA source

Medical Action Industries, Inc. 306 began a recall of Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds on 2026-05-13. FDA classified it as Class I and gives the reason as "Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within...". 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-2792-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-13
Posted: 2026-07-30
Recalling firm: Medical Action Industries, Inc. 306
Product: Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Handle Manifolds
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On 5/13/2026, Owens & Minor emailed recall notices to customers who were asked to do the following: Identify, segregate, and quarantine all impacted product. Other components within the convenience kits can still be used once kit is properly labeled with the warning label below. Add warning labels to affected Medical Action kits to ensure all users are aware of the actions to remove and discard Manifold component as well as actions identified below and in the enclosed Medline recall notice. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Labels state in part: Prior to use, remove & discard the Medline Namic Angiographic (The Manifold). Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. Complete and return the response form via email to [email protected] Report any quality problems or adverse events associated with the products listed in this notification to [email protected]
Quantity in commerce: 657
Distribution: US: AZ, CO
Product codes and lots: UDI-DI: 20809160490416. Lot/Expiration: 342513(1/16/2028), 336758(9/20/2027), 338977(1/16/2028)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2792-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2792-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-30

Product code OEZ

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)