Class 1 Device Recall Sterile Medline Convenience Kits

• Date Initiated by Firm: August 08, 2025
• Date Posted: September 26, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2593-2025
• Recall Event ID: 97495
• Product Classification: Orthopedic tray - Product Code OJH
• Product: Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
• Code Information: 1) DYNJ45701B, UDI-DI: 10193489856279(each), 40193489856270(case), Lot Number: 25GBF686
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• Manufacturer Reason for Recall: Convenience kits labeled as sterile have not gone through the sterilization process.
• FDA Determined Cause: Process control
• Action: Customers were alerted via email and telephone beginning 8/8/25 of a potential issue with the products. An URGENT MEDICAL DEVICE RECALL notification letter dated 8/22/25 was sent to customers. This communication is a follow-up to the notification you received from your Medline Sales Representative and to acknowledge the subsequent return of impacted product to Medline. This communication is to provide formal documentation of the recall for your records. No additional action is required to be taken. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Sterile Medline Convenience Kits. It has been identified that specific convenience kits labeled as sterile have not gone through the sterilization process. As a result, these kits are non-sterile. If the non-sterile kits are assumed sterile upon use, this could result in potential contamination of the sterile-field and an increased risk of patient infection that may require the use of intravenous or oral antibiotics. Refer to the enclosed list for all affected item number(s) and affected lot number(s). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax and to Medline Industries, LP. If you have any questions regarding this notification, please contact the Director, Regulatory Compliance at (smbrandel@medline.com). or Product Recall Specialist at HBarclay@Medline.com.
• Quantity in Commerce: 88 units
• Distribution: US Distribution to States of: FL, MD, NJ, TN
• 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.