FDA recall Z-1167-2024

Olympus Corporation of the Americas · Class II · device

Product

ESG PK CUTTING FORCEPS, 5MM, 33CM

Reason for recall

The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.

Key facts

Status
Ongoing
Initiation date
2023-12-15
Report date
2024-02-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2024