Z-2149-2025 Class II Ongoing
FDA device recall Z-2149-2025 was initiated by Jinan Bodor Cnc Machine Co Ltd on February 7, 2025 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- July 30, 2025
- Initiation Date
- February 7, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 20
Product Description
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).
Distribution Pattern
US
Code Information
The Accession Number is 2421628- 001.