FDA Device recall Z-0334-2024
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum)
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum) by Aizu Olympus, citing 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 end….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0334-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-25 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aizu Olympus |
| Distribution | US |
Product
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.
Reason
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
Identifiers
| code_info | Model Numbers: GIF-1TH190 (04953170343360), GIF-1TQ160 (Not recorded), GIF-2T160 (04953170307492), GIF-2TH180 (04953170…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0334-2024%22
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