STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R — Class II medical device recall Z-0641-2021
Terminated recall by GA HEALTH COMPANY LIMITED, reported 2020-12-30, distributed nationwide. Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
| Recall number | Z-0641-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GA HEALTH COMPANY LIMITED, Shatin N.T., N/A, Hong Kong SAR |
| Recall initiated | 2020-11-03 |
| Classified | 2020-12-18 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2021-09-03 |
| Distributed | Nationwide (US) |
| Quantity | 11,000 units |
| UPC / GTIN / UDI-DI | 04897106951116, 14897106951113, 24897106951110 |
| Lot numbers | 19121829 |
Product
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
Reason for recall
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
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-0641-2021. 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.