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 Injectable Implant 1.5cc Recalled by Merz North America, Inc. Due to The expiration date encoded in the UDI barcode...

Date: October 26, 2015
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, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.

Quantity: 1,616 units

Why Was This Recalled?

The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

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