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Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01 recallZ-1338-2026 · AVID Medical, Inc. · initiated Jan 2, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from AVID Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Equipment maintenance

What the company is doing

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.

Recall details

Recall number
Z-1338-2026
Status
Open, Classified
Initiated by the company
Jan 2, 2026
Posted by the FDA
Feb 9, 2026
Recalling firm
AVID Medical, Inc.
Quantity
1,500 units
Product code
LRO
Distribution
US Nationwide distribution in the states of New Jersey.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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