GIF-H190 — Class II medical device recall Z-0416-2024
Ongoing recall by Aizu Olympus Co., Ltd., reported 2023-12-06, distributed in FL, KY, MA, NJ, NY, PA. Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the s
| Recall number | Z-0416-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aizu Olympus Co., Ltd., Aizuwakamatsu, Japan |
| Recall initiated | 2023-10-16 |
| Classified | 2023-11-29 |
| Reported by FDA | 2023-12-06 |
| Distributed | FL, KY, MA, NJ, NY, PA |
| Quantity | 24 incorrectly |
| UPC / GTIN / UDI-DI | 04953170305290 |
| Serial numbers | 2312905, 2515895, 2628532 |
Product
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0416-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.