OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE — Class II medical device recall Z-0645-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-01-17, distributed nationwide. Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessin
| Recall number | Z-0645-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-11-20 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Distributed | Nationwide (US) |
| Quantity | 271 units |
| UPC / GTIN / UDI-DI | 04953170310386 |
| Model numbers | LTF-S190-10 |
Product
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.
Reason for recall
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
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-0645-2024. 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.