FDA-Device2024-01-24Class II
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Hazard
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
Sold states
Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.
Affected count
179 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0718-2024More 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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