CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report
Bodor's I series laser cutting machine recalled
Jinan Bodor Cnc Machine is recalling Bodor's I series laser cutting machine. The recall was initiated on 7 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2149-2025
- FDA event ID
- 97284
- Recalling firm
- Jinan Bodor Cnc Machine, Jinan, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Feb 2025
- FDA classified
- 23 Jul 2025
- Reported
- 30 Jul 2025
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 7 Feb 2025 | Recall initiated by company | |
| 23 Jul 2025 | Classified by FDA | +166 days |
| 30 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Bodor's I series laser cutting machine.
Where it was distributed
US
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
The Accession Number is 2421628- 001.
Where was it sold?
US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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