FDA-Device2024-08-14Class II
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Hazard
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
Affected count
253 Units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2505-2024More 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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