Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in JapanLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Olympus CorporationLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Aizu Olympus with 31 device recalls, 1 510(k) clearance and 1 warning letter. The most recent is a device recall dated Oct 31, 2025: Olympus OER-Elite.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 31, 2025 | Olympus OER-EliteClass II · Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules | Device recalls |
| Oct 31, 2025 | Olympus OER-ProClass II · Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules | Device recalls |
| Oct 31, 2025 | Olympus OER-MiniClass II · Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules | Device recalls |
| Oct 16, 2023 | PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPEClass II · Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction cha | Device recalls |
| Oct 16, 2023 | PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPEClass II · Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction cha | Device recalls |
| Oct 16, 2023 | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPEClass II · Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction cha | Device recalls |
| Oct 16, 2023 | GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPEClass II · Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction cha | Device recalls |
| Oct 16, 2023 | GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPEClass II · Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction cha | Device recalls |
| Nov 2, 2022 | Warning letter: Process validation, MDR reporting, Design controlsCDRH | Warning letters |
| Jan 28, 2005 | EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1K043487 · FDF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
