FDAClass II · Medical device · Recalled June 17, 2026

Halyard recall — AVID Medical, Inc.

Hazard: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2407-2026
Brand: AVID Medical
Classification: Class II
Units affected: 120 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Halyard, Pain Pack. Kit Code: AMPK48-01.

Affected products

Halyard

Companies & origin

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

Identifying details (verbatim from the notice)

Product codes / lots: Kit Code: AMPK48-01. UDI-DI: 10809160472798. Lot Number: 334669. Expiration Date: 8/27/2028.
Distribution: US Nationwide distribution in the state of Iowa.
Firm notified the public via: E-Mail
FDA event ID: 99021
Recall initiated: April 30, 2026
FDA classified: June 11, 2026
FDA report date: June 17, 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 5:00 AM UTC.

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