The FDA has posted 163 enforcement recalls from Olympus Corporation of the Americas since 2025, including 30 Class I (most serious) recalls. Most recent report: Apr 29, 2026.
Potential for detachment of a distal tip component of the device during use.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Firm name as filed with the FDA: “Olympus Corporation of the Americas”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.