Facility

SOPHYSA

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

Key facts

2recalls · 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)	3001587388
Establishment type	Manufacture Medical Device
Location	Rue Sophie Germain BESANCON Doubs, FR 25000
Registration status	Active · expires 2026
Parent company	SOPHYSA (owner-operator 10023919)
Brand names	SOPHYSA SHUNT

Activity by year

Recalls (2)
Inspections (3)

Devices registered here (1)

Shunt, Central Nervous System And Components
Product code JXG (opens in a new tab) · Class II · Neurology · 21 CFR 882.5550

Recalls & enforcement

Class IIOngoing2025-11-17
Customer complaints of Pressio monitor rebooting.
Class IIOngoing2024-04-09
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error…

FDA inspections (3)

NAI2025-06-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2023-06-07
No Action Indicated · Compliance: Devices
NAI2019-01-31
No Action Indicated · Compliance: 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.

All facilities operated by SOPHYSA

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. “SOPHYSA (FEI 3001587388) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001587388-sophysa/

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