Aizu Olympus Co., Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0328-2024)

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:

Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.

Product Classification:

Class II

Date Initiated: September 25, 2023

Date Posted: November 29, 2023

Recall Number: Z-0328-2024

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: 823 units

Code Information:

Model Number (UDI-DI): BF-UC180F (04953170356360), BF-UC190F (04953170399831).

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated