Class 2 Device Recall Medline Pill Splitters

• Date Initiated by Firm: May 11, 2022
• Create Date: June 24, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1287-2022
• Recall Event ID: 90196
• Product Classification: Pill crusher/cutter - Product Code OHY
• Product: Medline Pill Splitters; 1 each/box; 144 boxes/carton
• Code Information: Model Number: NON135000; UDI/DI:8019673489; Lot Numbers: 50920060001, 50920080001, 50920110001, 50921030001, 50921040001, 50921050001, 50921060001, 50921080001, 50921090001, 50921100001, 50921110001, 50921120001, 50922020001
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 224-931-1071
• Manufacturer Reason for Recall: Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.
• FDA Determined Cause: Process change control
• Action: The firm issued a recall notice to consignees on 05/11/2022 via mail. The letter instructs the consignee to check their stock, destroy affected product, and return the response form. On 5/16/2022, the firm sent out an updated recall notice.
• Quantity in Commerce: 840,087 each
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Panama, and Hongkong.
• 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.