Flux Technology Inc. recalls Lazervida 10W diode laser cutter and engraver with Lazervida shield.
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Lot / code information
None.
What the firm is doing
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 support@flux3dp.com.
DistributionShow detailsHide
US
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1878-2025
- FDA device classification · RHKOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Flux Technology Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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