The FDA has posted 119 enforcement recalls from Olympus Corporation of the Americas since 2025, including 3 Class I (most serious) recalls. Most recent report: Oct 7, 2026.
While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable.
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
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.