Merz Recalls Radiesse Injectable Implant Due to Incorrect Expiration Date
Merz North America is recalling 1,616 units of Radiesse (+) Lidocaine Injectable Implant because the expiration date on the packaging is incorrect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Merz North America, Inc. is recalling 1,616 units of Radiesse (+) Lidocaine Injectable Implant 1.5cc (P/N: 8063M0K1, Lot No. 100083189). The product is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
The recall was initiated because the expiration date encoded in the UDI barcode on the product carton and the peelable patient identification label is incorrect. The agency has classified this as a Class II recall.
The affected units were distributed nationwide, including in Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
- Manufacturer
- Merz North America, Inc.
- Hazard
- Affected units
- 1,616
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 100083189
Distribution
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