Data Foundry

Medical device recalls 2025

Lazervida 10W diode laser cutter and engraver with Lazervida shield — Class II medical device recall Z-1878-2025

Ongoing recall by Flux Technology Inc., reported 2025-06-11. Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas.

Recall numberZ-1878-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedFDA mandated
Recalling firmFlux Technology Inc., Taipei City, N/A, Taiwan
Recall initiated2025-02-19
Classified2025-06-03
Reported by FDA2025-06-11
Quantity91
Reason classeslabeling

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1878-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.