Facility

Vygon Verneuil

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

Key facts

6recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011237770
Establishment type	Sterilize Medical Device for Another Party (Contract Sterilizer)
Location	Parc Alata Verneuil En Halatte Oise, FR 60550
Registration status	Active · expires 2026
Parent company	VYGON S A (owner-operator 8020785)
Brand names	246X2; MICROFLEX

Activity by year

Recalls (6)
Inspections (1)

Devices registered here (1)

Set, Administration, Intravascular
Product code FPA (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440

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.

FDA inspections (1)

NAI2024-12-19
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Vygon Verneuil (FEI 3011237770) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011237770-vygon-verneuil/

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