Class 2 Device Recall Medline

• Date Initiated by Firm: July 31, 2026
• Date Posted: September 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3207-2026
• Recall Event ID: 99667
• Product Classification: Spinal epidural anesthesia kit - Product Code OFT
• Product: Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
• Code Information: UDI-DI 10195327506506 Lot 25BBK494
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 800-633-5463
• Manufacturer Reason for Recall: Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
• FDA Determined Cause: Under Investigation by firm
• Action: Firm began notifying customers on July 31, 2026 via email and first-class mail. Customers were instructed to discard any affected sterile convenience kits.
• Quantity in Commerce: 341
• Distribution: US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
• 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.