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FDA · Medical device recall

Lazervida 10W diode laser cutter and engraver with Lazervida shield

Recall started · FDA enforcement report June 11, 2025 Class II

Reason
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…
Status
Ongoing
Distribution
US
Enforcement report date
June 11, 2025
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
Flux Technology Inc.
Product
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Reason
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 pattern
US
Quantity
91
Codes and lots
None.
Recall started
Feb. 19, 2025
Voluntary or mandated
FDA Mandated
Device type
Laser Marker Or Engraver, Industrial Or Commercial
What the company told customers
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.
Recall number
Z-1878-2025

What this record is about

A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.

A generic icon of the kind of thing the record is aboutA simplified icon of the kind of thing the record is about and the phrases of the record's own text beside it.1 The record: Lazervida 10W diode laser cutter…2 In the record's words:3 Only the kind of thing is drawn4 The record's own words are below“Lazervida 10W Diode Laser Engraver does not fully meet currentFederal performance standards in certain areas.”LAZERVIDA 10W DIODE LASER…

“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.”Lazervida 10W diode laser cutter and engraver with Lazervida shield., FDA enforcement report, 2025-06-11. The caption is the record's own words.

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FDA device name: Laser Marker Or Engraver, Industrial Or Commercial

This recall among the others

  • FDA's enforcement report came 112 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-1878-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-1878-2025, June 11, 2025. "Lazervida 10W diode laser cutter and engraver with Lazervida shield." PlainRecords, https://plainrecords.com/recall/device/z-1878-2025/ (as of the day it was built).

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