Class 2 Device Recall Medline

• Date Initiated by Firm: April 27, 2026
• Date Posted: June 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2420-2026
• Recall Event ID: 98951
• Product Classification: CT biopsy tray - Product Code OFG
• Product: Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L
• Code Information: UDI-DI 10198459293535 Lots 26AME511 26AMG737
• 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 contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
• FDA Determined Cause: Process control
• Action: Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.
• Quantity in Commerce: 49,654 kits total
• Distribution: US Nationwide distribution. OUS distribution pending.
• 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.