Merz Recalls Radiesse Injectable Implant Due to Syringe Delivery Issues
Merz North America is recalling 1,591 units of Radiesse (+) Lidocaine Injectable Implant because the product could not be expelled from the syringe or needle.
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 the source text describes a functional defect (inability to expel product) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Merz North America, Inc. is recalling 1,591 units of Radiesse (+) Lidocaine, Injectable Implant 1.5cc (P/N: 8063M0K1, Lot #100088744). The product is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
The recall was initiated after complaints were reported that the Radiesse (+) product was unable to be expelled from the syringe and/or needle. The affected units were distributed nationwide in the United States, including the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, and WA.
Consumers and healthcare providers should stop using the affected product and contact Merz North America, Inc. for further instructions or a refund.
The recalled product
- Product
- 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.
- Manufacturer
- Merz North America, Inc.
- Hazard
- Affected units
- 1,591
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 (2)
- Model number: 8063M0K1
- Lot #100088744.
Distribution
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