Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2149-2025Class II

Bodor's I series laser cutting machine

Jinan Bodor Cnc Machine Co Ltd / initiated 2025-02-07 / Open, Classified

Jinan Bodor Cnc Machine Co Ltd began a recall of Bodor's I series laser cutting machine on . FDA classified it as Class II and gives the reason as "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)". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2149-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Jinan Bodor Cnc Machine Co Ltd
Product
Bodor's I series laser cutting machine.
Product code
RFE Laser Cutter
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).
FDA root cause
Radiation Control for Health and Safety Act
Action
Jinan 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'.
Quantity in commerce
20
Distribution
US
Product codes and lots
The Accession Number is 2421628- 001.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2149-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2149-2025Class IIOngoingFDA Mandated