Class 2 Device Recall Halyard

• Date Initiated by Firm: November 14, 2025
• Date Posted: December 15, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0929-2026
• Recall Event ID: 98045
• Product Classification: General surgery tray - Product Code LRO
• Product: Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
• Code Information: Catalog Number: JEMJ10-01. UDI-DI: 10809160443217. Lot Number: 1635770. Expiration Date: 7/26/2027.
• 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: Potential for incomplete seal on header bag.
• FDA Determined Cause: Nonconforming Material/Component
• Action: AVID Medical notified consignees on 11/14/2025 via emailed letter. Consignees were instructed to identify, segregate and quarantine all impacted product on hand, discontinue use of all affected units, and discard them. Distributors were instructed to notify customers if any of the affected kits were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form.
• Quantity in Commerce: 90 units
• Distribution: US distribution to GA, IL, NE, MD.
• 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.