Z-1338-2026Class II

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01

Name: Z-1338-2026 Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01
Creator: AVID Medical, Inc.
Published: 2026-01-02
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2026-01-02 / Open, Classified / root cause: manufacturing process

FDA source

AVID Medical, Inc. began a recall of Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01 on 2026-01-02. FDA classified it as Class II and gives the reason as "Tyvek bag seal issue which may compromise sterility of the kit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1338-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-02
Posted: 2026-02-09
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Product code: LRO General Surgery Tray
Reason for recall: Tyvek bag seal issue which may compromise sterility of the kit.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: 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.
Quantity in commerce: 1,500 units
Distribution: US Nationwide distribution in the states of New Jersey.
Product codes and lots: Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1338-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1338-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-09

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)