FDA Device recall Z-0416-2024
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
- FDA Device
- Class II
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE by Aizu Olympus, citing specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0416-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-16 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aizu Olympus |
| Distribution | FL, KY, MA, NJ, NY, PA |
Product
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Reason
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Identifiers
| code_info | UDI-DI 04953170305290 Serial Numbers 2515895, 2312905, 2628532 |
|---|
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-0416-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.