Vygon U.S.A.
Vygon U.S.A. has 3 FDA enforcement events on this register (11 product records) between 2018 and 2021: 3 device; the busiest year was 2018 with 2.
0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in PA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 15 Apr 2021 | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. | Device | Class II | 1 | Ongoing |
| 6 Dec 2018 | Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines. | Device | Class II | 2 | Terminated |
| 28 Feb 2018 | PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system. | Device | Class II | 8 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Vygon U.S.A. had?
3 enforcement events (11 product records) on this register, 2018–2021: 3 device.
Are any Vygon U.S.A. recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are Vygon U.S.A. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.