FDA recall Z-1262-2022

Product

Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

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-1262-2022