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FDA · Medical devicesClass I

Medical Action Industries, Inc. 306 medical device recall: Pack Angiography NCMC 3/Cs BANNER

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
99337
Recall initiated
May 13, 2026
Classified by FDA
Jul 30, 2026
Posted in Enforcement Report
Aug 5, 2026
Recalling firm
Medical Action Industries, Inc. 306
Firm location
Arden, NC, United States
Initiated by
Voluntary: Firm initiated
Products in this event
1

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on May 13, 2026. FDA classified it 78 days later, on Jul 30, 2026. Distribution reported by FDA: US: AZ, CO Medical Action Industries, Inc. 306 has 16 recalls in our records.

Recalled products (1)

  • Z-2792-2026 Class I Ongoing

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

    Codes / lots: UDI-DI: 20809160490416. Lot/Expiration: 342513(1/16/2028), 336758(9/20/2027), 338977(1/16/2028)

    Quantity: 657

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 99337
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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