FDA recall Z-1815-2022

Olympus Corporation of the Americas · Class II · device

Product

Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

Reason for recall

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

Distribution

Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA

Key facts

Status: Ongoing
Initiation date: 2022-08-12
Report date: 2022-10-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1815-2022