Olympus High Flow Insufflation Unit recall — FDA Z-1353-2026
Issue with software algorithm which may lead to overpressure events.
Overview of recall records associated with Olympus Corporation of the Americas, including dates, categories and classifications where available.
Classification mix: Class II: 23, Class I: 2.
Issue with software algorithm which may lead to overpressure events.
This page summarizes recall records in which the official source identifies Olympus Corporation of the Americas as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.