FDA Enforcement
Class II
Ongoing
Bodor's I series laser cutting machine.
Recall: Z-2149-2025
·
Reported July 30, 2025
Enforcement
- Recall Number
- Z-2149-2025
- Event ID
- 97284
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Jinan Bodor Cnc Machine Co Ltd
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- N/A
- Report Date
- July 30, 2025
- Initiation Date
- February 7, 2025
- Classification Date
- July 23, 2025
- Address
- NO.1299, XINLUO AVE HI-TECH ZONE, N/A, Jinan, N/A, N/A, China
Description
Bodor's I series laser cutting machine.
Reason
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).
Code Info
The Accession Number is 2421628- 001.
Distribution
US
Quantity
20