AVID Medical, Inc. recalls Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

Tyvek bag seal issue which may compromise sterility of the kit.

AVID Medical notified consignees on about 01/02/2026 via emailed URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter. Consignees were instructed to segregate and quarantine all affected lots, discard all affected lots on hand, and complete and return the provided Recall Response form. Distributors were instructed to notify all customers if further distributed.

• FDA enforcement recordOfficial FDA database entry for Z-1338-2026
• 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.