Aizu Olympus Co., Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0347-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.

Product Classification:

Class II

Date Initiated: September 25, 2023

Date Posted: November 29, 2023

Recall Number: Z-0347-2024

Event ID: 93222

Reason for Recall:

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Status: Ongoing

Product Quantity: 1577 units

Code Information:

Model Number (UDI-DI): URF-P6 (04953170340802), URF-P6R (04953170340833).

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated