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

FDA device recall Z-2964-2026 · posted 2026-08-14 · Open, Classified

Recall details

Recalling firm

AVID Medical, Inc.

Reason for recall

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.

Action taken

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."

Root cause

Process control

Status

Open, Classified

Product code

OKV

Quantity affected

40 packs

Distribution

US Nationwide distribution in the state of TX.

Date initiated

2026-07-10

Date posted

2026-08-14

Location

Toano, VA