FDA Device recall Z-0415-2024
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
- FDA Device
- Class II
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE 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-0415-2024 |
| 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
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
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 04953170305115 Serial Numbers 2635812, 2416423 |
|---|
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-0415-2024%22
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