CLASS I ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report

Halyard Sammc Angiography kit recalled by AVID Medical

AVID Medical is recalling Halyard Sammc Angiography kit, distributed in 7 states. The recall was initiated on 13 Mar 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel Number: SAMM066-15. UDI-DI (Kit Lot Numbers): 10809160388495 (1561685, 1575926, 1583048, 1584017, 1589652, 1595715, 1599634, 1605749, 1611810, 1621476, 1637222, 1637224, 1637225, 1643118, 1645143, 1645637, 1663929, 1663930, 1663931, 1663932).

Quantity recalled2,392 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1978-2026
FDA event ID: 98686
Recalling firm: AVID Medical, Toano, VA
Classification: Class I
Status: Ongoing
Recall initiated: 13 Mar 2026
FDA classified: 1 May 2026
Reported: 13 May 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Mar 2026	Recall initiated by company
1 May 2026	Classified by FDA	+49 days
13 May 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Product as listed by the FDA

Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.

Where it was distributed

US distribution to FL, IL, MO, MS, NC, NE, TX.

Florida Illinois Missouri Mississippi North Carolina Nebraska Texas

Questions about this recall

Is Halyard Sammc Angiography kit recalled?

Yes. AVID Medical recalled Halyard Sammc Angiography kit on 13 Mar 2026. The recall is Class I and its status is Ongoing. Recall number Z-1978-2026.

Why was it recalled?

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Which lots are affected?

Model Number: SAMM066-15. UDI-DI (Kit Lot Numbers): 10809160388495 (1561685, 1575926, 1583048, 1584017, 1589652, 1595715, 1599634, 1605749, 1611810, 1621476, 1637222, 1637224, 1637225, 1643118, 1645143, 1645637, 1663929, 1663930, 1663931, 1663932).

Where was it sold?

US distribution to FL, IL, MO, MS, NC, NE, TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from AVID Medical

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16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
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9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	AVID Medical	Sterility	Nationwide
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