Bodor's I series laser cutting machine.
This recall is currently active, issued July 23, 2025. It was issued by Jinan Bodor Cnc Machine Co Ltd No.1299, Xinluo Ave Hi-Tech Zone Jinan China.
- Recall Initiated
- February 7, 2025
- Posted
- July 23, 2025
- Recall Number
- Z-2149-2025
- Quantity
- 20
- Official Source
- View on FDA website ↗
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).
Distribution
US
Lot / Code Info
The Accession Number is 2421628- 001.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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'.