Aizu Olympus Co., Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0333-2024)
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:
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
Product Classification:
Class II
Date Initiated: September 25, 2023
Date Posted: November 29, 2023
Recall Number: Z-0333-2024
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: 680 units
Code Information:
Model Numbers: GF-UC140P-AL5 (04953170356322), GF-UCT180 (04953170356339), GF-UE160-AL5 (04953170356261).
Distribution Pattern:
Worldwide - US Nationwide distribution.
Voluntary or Mandated:
Voluntary: Firm initiated