Class II — Vygon U.S.A.
| Recalling firm | VYGON S A |
|---|---|
| Registered facility | View this company's 8 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | DualStop Caps defect causing leaks in affected product |
| Product | Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines. |
| Quantity | 339,800 |
| Distribution | US Nationwide distribution. |
| Initiated | 2018-12-06 |
| Classified | 2019-04-09 |
| Terminated | 2020-05-12 |
| Recall number | Z-1114-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vygon U.S.A. (Z-1114-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81866/
Alerts for VYGON S A
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.