FDA Medical Device Recalls (openFDA)
Flux Technology Inc.: Lazervida 10W diode laser cutter and engraver with Lazervida shield.
- Recall number
- Z-1878-2025
- Recalling firm
- Flux Technology Inc.
- Product
- Lazervida 10W diode laser cutter and engraver with Lazervida shield.
- Status
- Open, Classified
- Initiated
- 2025-02-19
- Posted
- 2025-06-03
- Terminated
- not on file
- 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.
- Root cause
- not on file
- 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 support@flux3dp.com.
- Quantity
- 91
- Distribution
- US
- Lot, serial or model codes
- None.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RHK
- Firm FEI
- 3015156297
- Firm city
- Taipei City
- Firm state
- not on file
- Firm country
- Taiwan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28