FDAClass I · Medical device · Recalled May 13, 2026

Halyard CATH LAB kit recall — AVID Medical, Inc.

Hazard: 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.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1973-2026
Brand: AVID Medical
Classification: Class I
Units affected: 228 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Halyard CATH LAB kit. Model Number: SACL75AM.

Affected products

Halyard CATH LAB kit

Companies & origin

Recalling firm location: Toano, VA, United States
Firm address: 9000 Westmont Dr, 23168-9351

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: SACL75AM. UDI-DI (Kit Lot Numbers): 10809160413586 (1599684, 1601393).
Distribution: US distribution to FL, IL, MO, MS, NC, NE, TX.
Firm notified the public via: E-Mail
FDA event ID: 98686
Recall initiated: March 13, 2026
FDA classified: May 1, 2026
FDA report date: May 13, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

Report a data error on this page