FDA recall Z-1264-2022

Olympus Corporation of the Americas · Class II · device

Product

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R

Reason for recall

Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

Distribution

CA FL MA MD MI NJ OH PR WI

Key facts

Status: Ongoing
Initiation date: 2022-04-20
Report date: 2022-06-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2022