Recalls / —

—#218204

Product

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm

AVID Medical, Inc.

Address

9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern

US Nationwide distribution in the states of New Jersey.

Timeline

Recall initiated

2026-01-02

Posted by FDA

2026-02-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #218204. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.