Facility

BIEN-AIR SURGERY SA

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

Key facts

1recalls · worst Class II

2inspections · 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)	3003800209
Establishment type	Foreign Private Label Distributor; Develop Specifications But Do Not Manufacture At This Facility; Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device
Location	rue de l Ouest 2b Le Noirmont Jura, CH 2340
Registration status	Active · expires 2026
Parent company	Bien-Air Surgery SA (owner-operator 10024150)
Brand names	Bur PM2-70 80k Steel 2.7 St; Bur PM2-70 80K Carb 4.5 St; Bur PM2-70 80K FC 3.5 St; Bur PM2-70 50K Carb Cone 7 St; ShBlade Straight 3.5 mm SM St; ShBur 15 DCR 3.1 mm St; Bur PM2-70 80K Diam 2.3 St; Bur PM2-70 80K Diam 3.5 St; Bur PM2-95 80K Diam 1 St; Bur OSSEOSTAP Carb 0.8 mm St; Bur PM2-70 80K Diam EC 6 St; Bur PM2-150 80k Diam 1 St

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (3)

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Product code ERL (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.4250
Bur, Ear, Nose And Throat
Product code EQJ (opens in a new tab) · Class I · Ear, Nose, Throat · 21 CFR 874.4140
Microdebrider, Ent, High Speed, Single Use, Reprocessed
Product code NLY (opens in a new tab) · Class I · Ear, Nose, Throat · 21 CFR 874.4140

Recalls & enforcement

Class IIOngoing2020-09-11
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

FDA inspections (2)

VAI2023-02-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-08-30
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.

All facilities operated by Bien-Air Surgery SA

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. “BIEN-AIR SURGERY SA (FEI 3003800209) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003800209-bien-air-surgery-sa/

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