Olympus Insufflation Units Recalled by FDA Due to Software Issues

The FDA has classified a recall of Olympus High Flow Insufflation Units (models UHI, UHI-2, UHI-3) as Class I, the most serious type, due to a software algorithm issue that could result in overpressure events. This recall involves the removal of these discontinued devices from use and sale. Olympus has reported two serious injuries associated with this issue, though no deaths have been reported.

Healthcare providers and facilities in possession of these units must immediately quarantine and cease usage of the affected devices. As no corrective solution is available, Olympus is removing them from the market. Failure to comply with the recall instructions could lead to serious patient harm, including death, during surgical procedures.