The Recall Desk

Manufacturer

Vygon U.S.A.

11 recalls in our database name Vygon U.S.A. as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
0
Most recent
2021-06-09

Of the 11 recalls from Vygon U.S.A. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • HighFDA (Devices)·Z-1689-2021·2021-06-09

    Vygon Dressing Change Kit Recalled for Sterile Barrier Failure Risk

    Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause infection.

    Product
    Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2019·2019-04-17

    Vygon DUALSTOP Red Caps Recalled for Defects Causing Leaks

    Vygon U.S.A. is recalling 339,800 DUALSTOP Red Caps used for intravascular lines because a defect causes leaks.

    Product
    Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2019·2019-04-17

    Vygon DUALSTOP White Caps Recalled for Defect Causing Leaks

    Vygon U.S.A. is recalling Vyon DUALSTOP White Caps used for intravascular lines because a defect causes leaks in the affected product.

    Product
    Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1637-2018·2018-05-16

    Vygon Recalls PICC Trays Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling 16,520 PICC Trays because potential friction holes may affect the sterility of the product.

    Product
    PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2018·2018-05-16

    Vygon U.S.A. Recalls Maximum Barrier Tray Due to Sterility Risk

    Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code AMS-9018CP) because potential friction holes may compromise product sterility.

    Product
    Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2018·2018-05-16

    Vygon Maximum Barrier Insertion Tray Recalled for Potential Sterility Compromise

    Vygon U.S.A. is recalling Maximum Barrier Insertion Trays because potential friction holes may affect the product's sterility.

    Product
    Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2018·2018-05-16

    Vygon Recalls Neonatal PICC Trays Due to Potential Sterility Issues

    Vygon U.S.A. is recalling 16,520 Neonatal PICC Trays because potential friction holes may affect the product's sterility.

    Product
    Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2018·2018-05-16

    Vygon Recalls PICC Insertion Trays Due to Potential Sterility Issues

    Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the sterility of the product.

    Product
    PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1633-2018·2018-05-16

    Vygon Recalls PICC Insertion Kits Due to Sterility Risk

    Vygon U.S.A. is recalling 16,520 PICC Kit units (Product Code AMS-7063-1) because potential friction holes may compromise product sterility.

    Product
    PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2018·2018-05-16

    Vygon Recalls Maximum Barrier Tray Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code MCITX-1) because potential friction holes may affect the product's sterility.

    Product
    Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2018·2018-05-16

    Vygon Recalls PICC Insertion Trays Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the product's sterility.

    Product
    PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Vygon

Founded
1962

Official website

Source: Wikidata (Q17032242), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.