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VYGON USA FDA Inspection Record

FEI 2245270 · Inspections, Form 483s, warning letters and import refusals

VYGON USA is an FDA-registered facility (FEI 2245270) located in Lansdale, PA, US. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection: May 25, 2017: Voluntary Action Indicated (VAI)
Inspections on record: 2 (2 VAI)
Last OAI inspection: None on record
Warning letters: None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm: 6, latest Apr 15, 2021

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
May 25, 2017	Voluntary Action Indicated (VAI)	Complaints (21 CFR 820.198(a)) Individual Report of Malfunction (21 CFR 803.50(a)(2))
Apr 14, 2011	Voluntary Action Indicated (VAI)	Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Nonconforming product control (21 CFR 820.90(a)) Complaints (21 CFR 820.198(a)) Lack of Written MDR Procedures (21 CFR 803.17) and 2 more

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Apr 15, 2021	Class II	Z-1689-2021	Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product… Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
Dec 6, 2018	Class II	Z-1114-2019	Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product… and 1 more product DualStop Caps defect causing leaks in affected product
Feb 28, 2018	Class II	Z-1633-2018	PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the… and 7 more products Potential friction holes may affect the sterility of the product.
Aug 28, 2014	Class II	Z-0113-2015	Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed… Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary…
Dec 17, 2012	Class II	Z-0937-2013	Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen… Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged…
May 11, 2012	Class II	Z-1797-2012	Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe… and 11 more products Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently…

FDA record score

5 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

8 records behind this number

Record	Date	Points x age weight	Adds
Inspection classified VAI	May 25, 2017	6 x 0.25	1.5
Class II recall Z-1689-2021, this FEI as the recalling firm	Apr 15, 2021	4 x 0.25	1
Class II recall Z-1114-2019, this FEI as the recalling firm	Dec 6, 2018	4 x 0.25	1
Class II recall Z-1633-2018, this FEI as the recalling firm	Feb 28, 2018	4 x 0.25	1
Class II recall Z-0113-2015, this FEI as the recalling firm	Aug 28, 2014	10 years or older, so it adds no points	0
Class II recall Z-0937-2013, this FEI as the recalling firm	Dec 17, 2012	10 years or older, so it adds no points	0
Class II recall Z-1797-2012, this FEI as the recalling firm	May 11, 2012	10 years or older, so it adds no points	0
Inspection classified VAI	Apr 14, 2011	10 years or older, so it adds no points	0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
Records	Last refreshed	Source as of	Status
Inspections	Nov 15, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions (warning letters, injunctions and other action types)	Nov 2, 2026	Newest record Oct 29, 2026	Current
Warning letter text	Nov 14, 2026	Newest record Nov 10, 2026	Current
Recalls (Enforcement Report)	Nov 15, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 15, 2026	Newest record Nov 5, 2026	Current

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Facility details

Company: Vygon U.S.A.
Location: Lansdale, PA (US)
Source: device