Vygon U recalls

Vygon U has 11 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 9 Jun 2021. 1 is still ongoing. The most frequent reason is sterility.

Total recalls11since 2018

Last 12 months0reported

Class I00% of total

Ongoing1latest 9 Jun 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 11 100%Class III 0 0%

Why vygon u is recalled

Sterility982%
Packaging Defects218%

Product types

Heart & Vascular Devices1091%
Other Medical Devices19%

By year

202119%
2019218%
2018873%

Ongoing vygon u recalls

1 active

Reported	Class	Recall	Company	Reason	Where
9 Jun 2021Device	CLASS II	Vygon Dressing Change w/ Maxiswab recalled by Vygon U	Vygon U	Sterility	Nationwide

All vygon u recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
9 Jun 2021Device	CLASS II	Vygon Dressing Change w/ Maxiswab recalled by Vygon U	Vygon U	Sterility	Nationwide
17 Apr 2019Device	CLASS II	Vyon Dualstop White Cap used for intravascular lines Product recalled	Vygon U	Packaging Defects	Nationwide
17 Apr 2019Device	CLASS II	Vygon Dualstop Red Cap used for intravascular lines Product recalled	Vygon U	Packaging Defects	Nationwide
16 May 2018Device	CLASS II	PICC Kit, Product recalled by Vygon U	Vygon U	Sterility	Nationwide
16 May 2018Device	CLASS II	Neonatal PICC Tray, Product recalled by Vygon U	Vygon U	Sterility	Nationwide
16 May 2018Device	CLASS II	PICC Insertion Tray, Product recalled by Vygon U	Vygon U	Sterility	Nationwide
16 May 2018Device	CLASS II	Maximum Barrier Tray, Product recalled by Vygon U	Vygon U	Sterility	Nationwide
16 May 2018Device	CLASS II	Maximum Barrier Tray, Product recalled by Vygon U	Vygon U	Sterility	Nationwide
16 May 2018Device	CLASS II	Maximum Barrier Insertion Tray, Product recalled by Vygon U	Vygon U	Sterility	Nationwide
16 May 2018Device	CLASS II	PICC Insertion Tray, Product recalled by Vygon U	Vygon U	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.