FDA Medical devices recall ·

Halyard SAMMC ANGIOGRAPHY kit recall

This is an FDA Class I recall — the most serious type.

Recall number
Z-1978-2026
Date
(initiated March 13, 2026)
Company / brand
AVID Medical, Inc.
9000 Westmont Dr, Toano, VA, United States
Category
Medical devices › Class I
Classification
Class I
Status
Ongoing
Units affected
2,392 kits
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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).

Distribution

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

States: Florida Illinois Missouri Mississippi North Carolina Nebraska Texas

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-1978-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.