Facility

Ulthera Inc

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

Key facts

4recalls · 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)	1012187
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	6501 Six Forks Rd Raleigh, NC, US 27615
Registration status	Active · expires 2026
Parent company	Merz North America, Inc. (owner-operator 9043404)

Activity by year

Recalls (4)
Inspections (3)

Devices registered here (2)

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Product code OHV (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4590
System, Imaging, Pulsed Echo, Ultrasonic
Product code IYO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560

Recalls & enforcement

Class IIOngoing2020-09-30
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Class IITerminated2016-05-20
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Class IITerminated2015-10-26
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
Class IITerminated2015-10-26
The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

FDA inspections (3)

NAI2025-10-28
No Action Indicated · Bioresearch Monitoring
NAI2023-06-22
No Action Indicated · Bioresearch Monitoring
VAI2018-07-26
Voluntary 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. “Ulthera Inc (FEI 1012187) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1012187-ulthera-inc/

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