Class 2 Device Recall Halyard

• Date Initiated by Firm: August 04, 2025
• Date Posted: September 05, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2530-2025
• Recall Event ID: 97452
• Product Classification: General surgery tray - Product Code LRO
• Product: Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
• Code Information: Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
• 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 open header bag seals, compromising sterility.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided.
• Quantity in Commerce: 57 units
• Distribution: US Nationwide distribution in the state of Florida.
• 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.