Bodor's I series laser cutting machine — Class II medical device recall Z-2149-2025
Ongoing recall by Jinan Bodor Cnc Machine Co Ltd, reported 2025-07-30. The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR
| Recall number | Z-2149-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Jinan Bodor Cnc Machine Co Ltd, Jinan, N/A, China |
| Recall initiated | 2025-02-07 |
| Classified | 2025-07-23 |
| Reported by FDA | 2025-07-30 |
| Quantity | 20 |
Product
Bodor's I series laser cutting machine.
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).
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.