RegWardenFDA facility compliance records
Company

VYGON S A

6 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 2 recalls; 2014: 1 recalls; 2018: 2 recalls; 2021: 1 recalls2’12’131’14’15’16’172’18’19’201’21’22’23’24’25’26
  • Recalls (6)

Registered facilities (8)

Recalls & enforcement

  • Class IIOngoing2021-04-15
    Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
  • Class IITerminated2018-12-06
    DualStop Caps defect causing leaks in affected product
  • Class IITerminated2018-02-28
    Potential friction holes may affect the sterility of the product.
  • Class IITerminated2014-08-28
    Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.
  • Class IITerminated2012-12-17
    Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
  • Class IITerminated2012-05-11
    Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “VYGON S A — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8020785-vygon-s-a/

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