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Vygon USA

Country not established FDA FEI 2245270

Devices
4
Registrations
FDA
FDA recalls
111 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Vygon USA makes

Vygon USA manufactures peripheral intravenous catheters, including the Leaderflex Mini and Nano lines for small-gauge access, midline catheters (3 Fr, 4 Fr, and 5 Fr), peripherally inserted central catheters (PICCs), and nutritional administration sets like Nutrifit.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

Company details

FDA FEI number
2245270
Address
2750 Morris Rd Suite A200, Lansdale, PA, 19446

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 11 recalls initiated by Vygon USA, the earliest on 2018-02-28 and the most recent on 2021-04-15. By recorded status: 1 ongoing and 10 terminated. The reasons filed fall into these groups: sterility or contamination and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 10
  • 2019 0
  • 2020 0
  • 2021 1
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

Showing the 10 most recent of 11 recalls.

  • 2021

    • 15 Apr 2021 Z-1689-2021 Class II Ongoing Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection Distribution: US Nationwide distribution in the state of PA.

  • 2018

    • 6 Dec 2018 Z-1114-2019 Class II Terminated DualStop Caps defect causing leaks in affected product Distribution: US Nationwide distribution.
    • 6 Dec 2018 Z-1115-2019 Class II Terminated DualStop Caps defect causing leaks in affected product Distribution: US Nationwide distribution.
    • 28 Feb 2018 Z-1633-2018 Class II Terminated Potential friction holes may affect the sterility of the product. Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
    • 28 Feb 2018 Z-1634-2018 Class II Terminated Potential friction holes may affect the sterility of the product. Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
    • 28 Feb 2018 Z-1635-2018 Class II Terminated Potential friction holes may affect the sterility of the product. Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
    • 28 Feb 2018 Z-1636-2018 Class II Terminated Potential friction holes may affect the sterility of the product. Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
    • 28 Feb 2018 Z-1637-2018 Class II Terminated Potential friction holes may affect the sterility of the product. Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
    • 28 Feb 2018 Z-1638-2018 Class II Terminated Potential friction holes may affect the sterility of the product. Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
    • 28 Feb 2018 Z-1639-2018 Class II Terminated Potential friction holes may affect the sterility of the product. Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Show all 11 recalls

  • 2018

    • 28 Feb 2018 Z-1640-2018 Class II Terminated Potential friction holes may affect the sterility of the product. Distribution: Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Frequently asked questions

How many devices does Vygon USA have in the registry?

The registry currently lists 4 devices for Vygon USA. Devices recorded under merged duplicate company entries are counted once.

Which registries list Vygon USA's devices?

Among its 4 most recently registered devices, Vygon USA has devices listed in FDA 510(k) (4 devices).

What risk classes do Vygon USA's devices fall under?

Among its 4 most recently registered devices, the classes recorded for Vygon USA's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Vygon USA?

FDA recall records list 11 recalls initiated by Vygon USA, the most recent initiated on 2021-04-15. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Vygon USA in the registry?

The most recently registered devices listed for Vygon USA include Leaderflex Mini and Leaderflex Nano, Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter, Vygon PICCs and Nutrifit.

Generated automatically from registry data and not verified by a human reviewer.