Aizu Olympus Co., Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0334-2024)

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:

Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

Product Classification:

Class II

Date Initiated: September 25, 2023

Date Posted: November 29, 2023

Recall Number: Z-0334-2024

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: 3627 units

Code Information:

Model Numbers: GIF-1TH190 (04953170343360), GIF-1TQ160 (Not recorded), GIF-2T160 (04953170307492), GIF-2TH180 (04953170339745), GIF-H170 (04953170334115), GIF-H180 (04953170339769), GIF-H180J (04953170307539), GIF-H190 (04953170305290), GIF-HQ190 (04953170305276), GIF-LV1 (04953170312373), GIF-N180 (04953170307508), GIF-Q150 (04953170307485), GIF-Q160Z (04953170066795), GIF-Q180 (04953170307522), GIF-XP180N (04953170307515), GIF-XP190N (04953170305313), GIF-XTQ160 (04953170339837).

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated