FDA-Device2024-04-03Class II
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Hazard
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
Sold states
Domestic: OUS Only; International distribution in the states of Australia, Chile, Germany, Hong Kong, Japan, New Zealand and Singapore.
Affected count
17 Units (OUS Only)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1384-2024More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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