Home / Recalls / Medical Devices
Olympus Corporation of the Americas recalls Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Recalled June 22, 2022 · FDA recall Z-1264-2022 · Olympus Corporation of the Americas
Hazard
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. · FDA Class II
Units
4 units
Sold at
CA FL MA MD MI NJ OH PR WI
Description
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.
Product
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →