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RecallWatchMedical Device Safety
Class IIOngoingZ-1878-2025

Flux Technology Inc. recalls Lazervida 10W diode laser cutter and engraver with Lazervida shield.

Flux Technology Inc.Taipei City, TaiwanReported Jun 11, 2025 · 1 year ago
Legal News Analyst ·

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 details

US

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

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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