Olympus Corporation of the Americas
FDA Regulatory Profile
Olympus Corporation of the Americas appears in FDA public data with 415 recalls — including 44 Class I (most serious) —, 1 510(k) clearance, 9 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-3035-2026, Class II) was initiated on August 18, 2026. Its most recent 510(k) clearance was granted on August 7, 2014.
Summary
- Total Recalls
- 415 (44 Class I)
- 510(k) Clearances
- 1
- Inspections
- 9
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3035-2026 | Class II | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Elec | August 18, 2026 |
| Z-2761-2026 | Class II | Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit d | July 7, 2026 |
| Z-2776-2026 | Class II | Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 | June 16, 2026 |
| Z-2676-2026 | Class II | Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscop | June 5, 2026 |
| Z-2720-2026 | Class II | Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194. | May 5, 2026 |
| Z-2718-2026 | Class II | Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. | May 5, 2026 |
| Z-2721-2026 | Class II | Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. | May 5, 2026 |
| Z-2719-2026 | Class II | Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. | May 5, 2026 |
| Z-1898-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included | March 25, 2026 |
| Z-1908-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. | March 25, 2026 |
| Z-1901-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. | March 25, 2026 |
| Z-1899-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 | March 25, 2026 |
| Z-1904-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. | March 25, 2026 |
| Z-1907-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. | March 25, 2026 |
| Z-1909-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. | March 25, 2026 |
| Z-1903-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115. | March 25, 2026 |
| Z-1900-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 | March 25, 2026 |
| Z-1905-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. | March 25, 2026 |
| Z-1902-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. | March 25, 2026 |
| Z-1906-2026 | Class II | OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. | March 25, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133538 | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE | August 7, 2014 |