FDA-Device2024-01-24Class II
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Hazard
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
Sold states
US Nationwide. Global Distribution
Affected count
236 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0717-2024More 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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