Facility

AROBELLA MEDICAL, LLC

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

Key facts

1recalls · 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)	3007225330
Establishment type	Manufacture Medical Device
Location	111 Cheshire Lane, Suite 100 Minnetonka, MN, US 55305
Registration status	Active · expires 2026
Parent company	Arobella Medical, LLC (owner-operator 10024460)
Brand names	Qoustic Wound Therapy System

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Wound Cleaner, Ultrasound
Product code NRB (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4410
Lavage, Jet
Product code FQH (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5475

Recalls & enforcement

Class IITerminated2012-11-05
This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.

FDA inspections (1)

NAI2016-05-24
No Action Indicated · Compliance: 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 Arobella Medical, LLC

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. “AROBELLA MEDICAL, LLC (FEI 3007225330) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007225330-arobella-medical-llc/

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