FDAJanuary 29, 2020device
Class IV New Era medical laser device
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
What to do
FDA enforcement status: Ongoing
Brands named
inova lasersinova
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDALaser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.2025-06-30
- FDALaser light show projectors manufactured by BLS, Model PURE 5000/10000.2025-06-30
- FDALaser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.2025-06-30
- FDAFusion Pro 24, Model 170002024-08-08
- FDAQUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mountin...2018-01-26
- FDAQUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mountin...2018-01-26
- FDAX-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.2017-07-24
- FDABeijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers2017-07-03
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