ClearanceBrief
Recall Z-2149-2025 ยท RFE Laser Cutter

Jinan Bodor Cnc Machine Co Ltd

Bodor's I series laser cutting machine.

DateJul 23, 2025 (initiated Feb 7, 2025)
StatusOpen, Classified
ReasonThe Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2).
Root causeRadiation Control for Health and Safety Act
ActionJinan 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'.
Quantity20
DistributionUS
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.