Class 2 Device Recall Halyard

• Date Initiated by Firm: July 10, 2026
• Date Posted: August 14, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2964-2026
• Recall Event ID: 99443
• Product Classification: Obstetrical kit - Product Code OKV
• Product: Halyard LAVH PACK, Model/Catalog Number: USAR053-11
• Code Information: UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027
• FEI Number: 1047429
• Recalling Firm/ Manufacturer: AVID Medical, Inc.; 9000 Westmont Dr; Toano VA 23168-9351
• For Additional Information Contact: Marlene Jones; 757-566-3510
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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."
• Quantity in Commerce: 40 packs
• Distribution: US Nationwide distribution in the state of TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.