FDA recall Z-1375-2024

Olympus Corporation of the Americas · Class II · device

Product

Insufflation unit, UHI-4.

Reason for recall

Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".

Distribution

Domestic: Nationwide Distribution.

Key facts

Status: Ongoing
Initiation date: 2023-09-25
Report date: 2024-04-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1375-2024