Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Radiesse (+) Lidocaine Recalled by Merz North America, Inc. Due to Complaints reported of Radiesse (+) unable to be...

Date: May 20, 2016
Company: Merz North America, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Merz North America, Inc. directly.

Affected Products

Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.

Quantity: 1,591 units

Why Was This Recalled?

Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Merz North America, Inc.

Merz North America, Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report