Halyard Transport Bag Kit Recalled for Compromised Sterility

Agency Publication Date: February 9, 2026

Summary

AVID Medical, Inc. is recalling approximately 1,500 Halyard Transport Bag Kits due to an issue with the Tyvek bag seal. This defect can compromise the sterility of the medical kit, which is intended to be used in clinical environments where sterile equipment is necessary. If you have any of these kits in your inventory, you should stop using them immediately and contact the manufacturer or your distributor to arrange for a return, replacement, or correction.

Risk

A compromised seal on the Tyvek bag means the contents of the kit may no longer be sterile. Using non-sterile medical equipment in clinical settings can lead to serious patient infections or complications.

What You Should Do

Identify the affected products by checking the kit code and lot information on your packaging. This recall specifically affects Halyard Transport Bag Kits with Kit Code LIFE0080-01 and Lot Number 1650056.
Check for the expiration date of 07/24/2028 and the UDI-DI 10809160314500 on the product label.
Stop using the recalled product immediately to prevent the risk of infection from non-sterile equipment.
Contact AVID Medical, Inc. or your medical supply distributor to arrange for a return, replacement, or correction of the affected units.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Halyard TRANSPORT BAG KIT

Model / REF:

LIFE0080-01

Lot Numbers:

1650056 (Exp 07/24/2028)

UDI:

10809160314500

Recall #: Z-1338-2026

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98298

Status: Active

Manufacturer: AVID Medical, Inc.

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 1,500 units

Distributed To: New Jersey

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify the affected products by checking the kit code and lot information on your packaging. This recall specifically affects Halyard Transport Bag Kits with Kit Code LIFE0080-01 and Lot Number 1650056.

Check for the expiration date of 07/24/2028 and the UDI-DI 10809160314500 on the product label.

Stop using the recalled product immediately to prevent the risk of infection from non-sterile equipment.

Contact AVID Medical, Inc. or your medical supply distributor to arrange for a return, replacement, or correction of the affected units.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.