Aizu Olympus Co., Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0330-2024)
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:
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Product Classification:
Class III
Date Initiated: September 25, 2023
Date Posted: November 29, 2023
Recall Number: Z-0330-2024
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: 3 units
Code Information:
Model Number (UDI-DI): CHF-BP30 (04953170068751), CHF-CB30L (04953170340154), CHF-P60 (Not recorded).
Distribution Pattern:
Worldwide - US Nationwide distribution.
Voluntary or Mandated:
Voluntary: Firm initiated