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Vygon U.S.A. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · May 25, 2017
No warning letters matched by name

Inspections 2

0 OAI

Recalls 11

0 Class I (0%)

Warning letters 0 None on file

510(k) clearances 0 None on file

Vygon U.S.A. has 11 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Vygon U.S.A." is on file.

What these totals cover: FDA records filed under the name "Vygon U.S.A." and its spelling variant "Vygon U".

Latest recall: Z-1689-2021 · Class II · Apr 15, 2021
Latest inspection: May 25, 2017 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	11	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	2	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Vygon U.S.A.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Vygon U.S.A.: FDA inspections per year

Year	Inspections	Recall records
2026	0	0
2025	0	0
2024	0	0
2023	0	0
2022	0	0
2021	0	1
2020	0	0
2019	0	0
2018	0	10
2017	1	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent recalls

11 recall records from Feb 28, 2018 to Apr 15, 2021.

Number	Class	Product	Date
Z-1689-2021	Class II	Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code…	Apr 15, 2021
Z-1115-2019	Class II	Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap…	Dec 6, 2018
Z-1114-2019	Class II	Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used…	Dec 6, 2018
Z-1633-2018	Class II	PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular…	Feb 28, 2018
Z-1640-2018	Class II	PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into…	Feb 28, 2018
Z-1639-2018	Class II	PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into…	Feb 28, 2018
Z-1635-2018	Class II	Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into…	Feb 28, 2018
Z-1634-2018	Class II	Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into…	Feb 28, 2018
Z-1637-2018	Class II	PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular…	Feb 28, 2018
Z-1636-2018	Class II	Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of…	Feb 28, 2018
Z-1638-2018	Class II	Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the…	Feb 28, 2018

Recent FDA inspections

2 inspections from Apr 14, 2011 to May 25, 2017.

Date	Site	Product	Classification	FEI
May 25, 2017	Lansdale, PA	Devices	Voluntary Action Indicated (VAI)	2245270
Apr 14, 2011	Lansdale, PA	Devices	Voluntary Action Indicated (VAI)	2245270

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 2245270	Lansdale, PA	2	May 25, 2017

Vygon U.S.A. and the FDA: common questions

Has Vygon U.S.A. received an FDA warning letter?

No FDA warning letter addressed to the name "Vygon U.S.A." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Vygon U.S.A. received an FDA Form 483?

FDA has not published a Form 483 for "Vygon U.S.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Vygon U.S.A.?

The most recent FDA inspection on file ended May 25, 2017 at Lansdale, PA and was classified VAI. FDA has 2 inspections of Vygon U.S.A. on file.

Has Vygon U.S.A. had an FDA recall?

Yes. Vygon U.S.A. has 11 FDA recalls on record. The most recent started Apr 15, 2021.

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