Facility

AERIN MEDICAL INC.

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)	3011625895
Establishment type	Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility
Location	2565 Leghorn St. Mountain View, CA, US 94043
Registration status	Active · expires 2026
Parent company	Aerin Medical Inc. (owner-operator 10050618)
Brand names	Vivaer ARC Stylus; Vivaer Stylus

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Electrosurgical, Cutting & Coagulation & Accessories
Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400

Recalls & enforcement

Class IIOngoing2024-11-12
Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.

FDA inspections (2)

NAI2025-09-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2017-10-27
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.

All facilities operated by Aerin Medical Inc.

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. “AERIN MEDICAL INC. (FEI 3011625895) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011625895-aerin-medical-inc/

Not open yet

Alerts for AERIN MEDICAL INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.