Facility

VYGON S A

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

Key facts

6recalls · worst Class II

3inspections · worst VAI

—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)	3009291251
Establishment type	Manufacture Medical Device
Location	5 Rue Adeline Ecouen Ile-de-France, FR 95440
Registration status	Active · expires 2026
Parent company	VYGON S A (owner-operator 8020785)
Brand names	Latex-Free Bionector

Activity by year

Recalls (6)
Inspections (3)

Devices registered here (1)

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Product code FOZ (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5200

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 (3)

NAI2026-03-19
No Action Indicated · Compliance: Devices
NAI2026-03-19
No Action Indicated · Compliance: Devices
NAI2018-05-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 S A (FEI 3009291251) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009291251-vygon-s-a/

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