FDA Device recall Z-0640-2021
STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8…
- FDA Device
- Class II
- terminated
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8… by Ga Health, citing suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0640-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-03 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ga Health |
| Distribution | US |
Product
STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1
Reason
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Identifiers
| code_info | Lot Numbers: 19121830, 20031604 Unit UDI: 04897106951109 Box UDI: 24897106951103 Carton Box UDI: 24897106951103 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0640-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.