Aizu Olympus Co., Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0343-2024)

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:

Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion. - Model Number: SIF-Q180.

Product Classification:

Class II

Date Initiated: September 25, 2023

Date Posted: November 29, 2023

Recall Number: Z-0343-2024

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: 32 units

Code Information:

Model Number (UDI-DI): SIF-Q180 (04953170339936)

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated