Z-2149-2025Class II
Bodor's I series laser cutting machine
Jinan Bodor Cnc Machine Co Ltd / initiated 2025-02-07 / Open, Classified
Jinan Bodor Cnc Machine Co Ltd began a recall of Bodor's I series laser cutting machine on . FDA classified it as Class II and gives the reason as "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)". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2149-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Jinan Bodor Cnc Machine Co Ltd
- Product
- Bodor's I series laser cutting machine.
- Product code
- RFE Laser Cutter
- 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 root 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
- Product codes and lots
- The Accession Number is 2421628- 001.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2149-2025 | Class II | Ongoing | FDA Mandated |
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