Class 2 Device Recall MEDLINE CONVENIENCE KITS

• Date Initiated by Firm: February 27, 2026
• Date Posted: April 17, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1889-2026
• Recall Event ID: 98601
• 510(K)Number: K020393
• Product Classification: Drape, surgical - Product Code KKX
• Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
• Code Information: DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895
• 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: Unapproved design changes to the products outside of the 510(k) clearance.
• FDA Determined Cause: Component change control
• Action: On February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
• Quantity in Commerce: 270,311 total
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
• 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.

• 510(K) Database: 510(K)s with Product Code = KKX