Aizu Olympus Co., Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0341-2024)

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:

Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S.

Product Classification:

Class II

Date Initiated: September 25, 2023

Date Posted: November 29, 2023

Recall Number: Z-0341-2024

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: 3101 units

Code Information:

Model Number (UDI-DI): PCF-H180AI (04953170339875), PCF-H180AL (04953170339899), PCF-H190DI (04953170363696), PCF-H190DL (04953170363672), PCF-H190I (04953170305214), PCF-H190L (04953170305191), PCF-H190TI (04953170420719), PCF-H190TL (04953170420702), PCF-HQ190I (04953170416132), PCF-HQ190L (04953170416118), PCF-PH190I (04953170305252), PCF-PH190L (04953170305238), PCF-Q180AI (04953170307713), PCF-Q180AL (04953170307720), PCF-S (04953170339912).

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated