FDA Medical devices recall ·
Lazervida 10W diode laser cutter and engraver with Lazervida shield recall
- Recall number
- Z-1878-2025
- Date
- (initiated February 19, 2025)
- Company / brand
- Flux Technology Inc.
9 F; No. 465 Zhongxiao E. Rd., Sec. 6, Taipei City, N/A, Taiwan - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 91
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
None.
Distribution
US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1878-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.