Bodor's I series laser cutting machine.
FDA device recall Z-2149-2025 · posted 2025-07-23 · Open, Classified
Recall details
- Recalling firm
- Jinan Bodor Cnc Machine Co Ltd
- 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).
- 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'.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- RFE
- Quantity affected
- 20
- Distribution
- US
- Date initiated
- 2025-02-07
- Date posted
- 2025-07-23
- Location
- Jinan, China
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