Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Summary
The FDA issued a Class II for Lazervida 10W diode laser cutter and engraver with Lazervida shield. by Flux Technology Inc.. Reason: Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not inc.
Details
Source
Device Recall
External ID
Z-1878-2025
Action Date
2025-06-11
Status
Ongoing
Category
device
Product Description
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Lot/Code Info: None.
Quantity Affected: 91
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.
Distribution
US
Type: FDA Mandated
Recall Initiated: 2025-02-19
Company
Taipei City, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Flux Technology Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Flux Technology Inc. have FDA actions?
This is the only FDA action we have on record for Flux Technology Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1878-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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