FDA recall Z-1559-2022

Aizu Olympus Co., Ltd. · Class II · device

Product

EVIS EXERA III Bronchovideoscope

Reason for recall

The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.

Distribution

US Nationwide distribution in the states of FL, IL, NC, PA & TX.

Key facts

Status
Terminated
Initiation date
2022-07-20
Report date
2022-08-31
Termination date
2025-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aizuwakamatsu, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1559-2022