Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1878-2025Class II

Lazervida 10W diode laser cutter and engraver with Lazervida shield

Flux Technology Inc. / initiated 2025-02-19 / Open, Classified / root cause: labeling and UDI

Flux Technology Inc. began a recall of Lazervida 10W diode laser cutter and engraver with Lazervida shield on . FDA classified it as Class II and gives the reason as "Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1878-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Flux Technology Inc.
Product
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Product code
RHK Laser Marker Or Engraver, Industrial Or Commercial
Reason for recall
Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector, key switch, specific labels and manual instructions required under current regulations.
Root cause tag
labeling and UDI
Action
Customer Notification Letters were sent informing customers of Noncompliance, instructions of installation process and safety enhancement kit to be sent. Flux also provided customers with contact info for any questions or require assistance, Flux customer support team is available at [email protected].
Quantity in commerce
91
Distribution
US
Product codes and lots
None.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1878-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1878-2025Class IIOngoingFDA Mandated