Class 2 Device Recall

• Date Initiated by Firm: February 07, 2025
• Date Posted: July 23, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2149-2025
• Recall Event ID: 97284
• Product Classification: Laser cutter - Product Code RFE
• Product: Bodor's I series laser cutting machine.
• Code Information: The Accession Number is 2421628- 001.
• Recalling Firm/ Manufacturer: Jinan Bodor Cnc Machine Co Ltd; NO.1299, XINLUO AVE HI-TECH ZONE; Jinan China
• Manufacturer Reason for Recall: The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: Jinan Bodor CNC Machine Co. Ltd., and its subsidiary, Bodor Laser Inc., (collectively and individually, Bodor ) sent letters to customers to inform them the FDA has determined that i Series Products fail to meet certain applicable Federal Standards. The letter also provides Corrective Action Plan and instructions of 'Continued Use of Product While Corrective Actions are Pending'.
• Quantity in Commerce: 20
• Distribution: US
• 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.