FDA Device recall Z-0288-2024
EVIS EXERA III Gastrointestinal Videoscope
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of EVIS EXERA III Gastrointestinal Videoscope by Olympus, citing sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0288-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-02 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
Product
EVIS EXERA III Gastrointestinal Videoscope
Reason
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Identifiers
| code_info | Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers. |
|---|
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-0288-2024%22
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