Class 2 Device Recall Halyard, Pain Pack

• Date Initiated by Firm: April 30, 2026
• Date Posted: June 11, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2407-2026
• Recall Event ID: 99021
• Product Classification: Orthopedic tray - Product Code OJH
• Product: Halyard, Pain Pack. Kit Code: AMPK48-01.
• Code Information: Kit Code: AMPK48-01. UDI-DI: 10809160472798. Lot Number: 334669. Expiration Date: 8/27/2028.
• 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: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
• FDA Determined Cause: Process control
• Action: AVID Medical notified consignees on about 04/30/2026 via emailed letter. Consignees were instructed to identify, segregate and quarantine all affected units on hand, discard all impacted kits and complete and return the provided Response Form. Distributors were instructed to ensure all end-users are appropriately notified and maintain records of effectiveness.
• Quantity in Commerce: 120 kits
• Distribution: US Nationwide distribution in the state of Iowa.
• 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.