Halyard LAVH PACK, Model/Catalog Number: USAR053-11 recallZ-2964-2026 · AVID Medical, Inc. · initiated Jul 10, 2026

Open, Classified

Is my device affected?

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.
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.
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

A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in alignment with the manufacturer s recommendation.

FDA root cause category: Process control

What the company is doing

Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to its consignees on 7/10/2026 via email. The notice explained the issue, potential risks to health, and requested the following: "ACTIONS TO TAKE: " DO NOT USE AND DISCARD the Clearify Visualization System (Component# 5303907) located in the convenience kit identified in Table 1 above. All other components in the kits may continue to be used. " Add warning labels to affected AVID kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. Please contact your Sales Representative if pre-printed labels are needed. " Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. " Complete the attached Recall Response Form and return by July 22, 2026."

Recall details

Recall number: Z-2964-2026
Status: Open, Classified
Initiated by the company: Jul 10, 2026
Posted by the FDA: Aug 14, 2026
Recalling firm: AVID Medical, Inc.
Quantity: 40 packs
Product code: OKV
Distribution: US Nationwide distribution in the state of TX.

Product description

Halyard LAVH PACK, Model/Catalog Number: USAR053-11

Code information (models, lots, serial numbers)

UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027

Devices named in this recall

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

Halyard USAR053-11_0004
Avid Medical, Inc. · Obstetrical kit
2 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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