FDA Recall
Open, Classified
Bodor's I series laser cutting machine.
Recall: Z-2149-2025
·
Initiated February 7, 2025
Recall
- Recall Number
- Z-2149-2025
- Event Number
- 97284
- Firm
- Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China
- FEI Number
- 3008620561
- Product Code
- RFE
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- February 7, 2025
- Posted
- July 23, 2025
Description
Bodor's I series laser cutting machine.
Reason
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).
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'.
Distribution
US
Quantity
20