Olympus Corporation of the Americas

FDA Regulatory Profile

Summary

Total Recalls
407 (44 Class I)
510(k) Clearances
1
Inspections
9
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1898-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be includedMarch 25, 2026
Z-1903-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.March 25, 2026
Z-1908-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.March 25, 2026
Z-1907-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.March 25, 2026
Z-1899-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111March 25, 2026
Z-1905-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.March 25, 2026
Z-1900-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112March 25, 2026
Z-1906-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.March 25, 2026
Z-1902-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.March 25, 2026
Z-1904-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.March 25, 2026
Z-1901-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.March 25, 2026
Z-1909-2026Class IIOER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.March 25, 2026
Z-1854-2026Class IIOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.March 23, 2026
Z-1853-2026Class IIOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.March 23, 2026
Z-1852-2026Class IIOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.March 23, 2026
Z-1851-2026Class IIOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.March 23, 2026
Z-1694-2026Class IIBrand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser SyFebruary 27, 2026
Z-1695-2026Class IIBrand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFLFebruary 27, 2026
Z-1638-2026Class IIBrand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar CuttiFebruary 25, 2026
Z-1643-2026Class IIBrand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/CFebruary 25, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K133538VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE August 7, 2014