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 | Ongoing |
| Reason | Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection |
| Product | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. |
| Quantity | 8,320 units |
| Distribution | US Nationwide distribution in the state of PA. |
| Initiated | 2021-04-15 |
| Classified | 2021-05-28 |
| Recall number | Z-1689-2021 |
| 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-1689-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87802/
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