Recall Ledger

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. recall (AVID Medical, Inc.)

Medical deviceClass IIOngoing

Summary: AVID Medical, Inc. is recalling Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.. Reason: Tyvek bag seal issue which may compromise sterility of the kit.

What is being recalled

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

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of New Jersey. (states named: New Jersey)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1338-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJanuary 2, 2026
ReportedFebruary 18, 2026
CompanyAVID Medical, Inc.
Company locationToano, VA, United States
Initiated byVoluntary: Firm initiated
Quantity1,500 units

More recalls from AVID Medical, Inc. · all medical device recalls · recalls from January 2026

Official FDA record