Olympus Corporation of the Americas

FDA Regulatory Profile

Summary

Total Recalls
391 (44 Class I)
510(k) Clearances
1
Inspections
9
Compliance Actions
2

Recent Recalls

NumberClassProductDate
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-1643-2026Class IIBrand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/CFebruary 25, 2026
Z-1644-2026Class IIBrand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog February 25, 2026
Z-1641-2026Class IIBrand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps ModeFebruary 25, 2026
Z-1639-2026Class IIBrand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest BipolarFebruary 25, 2026
Z-1642-2026Class IIBrand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog February 25, 2026
Z-1640-2026Class IIBrand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog NuFebruary 25, 2026
Z-1638-2026Class IIBrand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar CuttiFebruary 25, 2026
Z-1612-2026Class IIOlympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.February 12, 2026
Z-1610-2026Class IIOlympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.February 12, 2026
Z-1611-2026Class IIOlympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.February 12, 2026
Z-1613-2026Class IIOlympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.February 12, 2026
Z-1488-2026Class IIOlympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 hasJanuary 29, 2026
Z-1489-2026Class IIOlympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 hJanuary 29, 2026
Z-1352-2026Class IOlympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cJanuary 16, 2026
Z-1353-2026Class IOlympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominaJanuary 16, 2026
Z-1354-2026Class IOlympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominalJanuary 16, 2026
Z-1494-2026Class IIBrand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE LitJanuary 8, 2026
Z-1292-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product DescJanuary 7, 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