Olympus Corporation of the Americas: Medical Device Recall in 2022 - (Recall #: Z-1263-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6

Product Classification:

Class II

Date Initiated: April 20, 2022

Date Posted: June 22, 2022

Recall Number: Z-1263-2022

Event ID: 90195

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.

Status: Ongoing

Product Quantity: 2 units

Code Information:

UDI-DI: 04953170340802 Serial Number: 2836210 2834747I

Distribution Pattern:

CA FL MA MD MI NJ OH PR WI

Voluntary or Mandated:

Voluntary: Firm initiated