FDAClass I · Medical device · Recalled May 13, 2026

Halyard CARDIAC CATH PACK 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-1970-2026
Brand: AVID Medical
Classification: Class I
Units affected: 222 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

Affected products

Halyard CARDIAC CATH PACK 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: 1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159). 2. Model Number: WAFB208-02. UDI-DI (Kit Lot Numbers): 10809160424759 (1615954, 1653009).
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.

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