AVID Medical, Inc. recalls Halyard

Potential for incomplete seal on header bag.

AVID Medical notified consignees on 11/14/2025 via emailed letter. Consignees were instructed to identify, segregate and quarantine all impacted product on hand, discontinue use of all affected units, and discard them. Distributors were instructed to notify customers if any of the affected kits were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form.

• FDA enforcement recordOfficial FDA database entry for Z-0928-2026
• FDA device classification · LROOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4370The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find AVID Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.