FDA recall Z-0229-2025

Olympus Corporation of the Americas · Class II · device

Product

Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)

Reason for recall

During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-08-23
Report date: 2024-11-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0229-2025