CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report
Radiesse (+) Lidocaine, Injectable Implant 1.5cc recalled
Merz North America is recalling Radiesse (+) Lidocaine, Injectable Implant 1.5cc, distributed nationwide in the US. The recall was initiated on 20 May 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2607-2016
- FDA event ID
- 74252
- Recalling firm
- Merz North America, Raleigh, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 May 2016
- FDA classified
- 19 Aug 2016
- Reported
- 31 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 May 2016 | Recall initiated by company | |
| 19 Aug 2016 | Classified by FDA | +91 days |
| 31 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution in 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.
Nationwide ArkansasCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNew JerseyNevadaNew York
Questions about this recall
Why was it recalled?
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Which lots are affected?
Model number: 8063M0K1, Lot #100088744.
Where was it sold?
US Nationwide Distribution in 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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Merz North America
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Coaptite Injectable Implant, injectable, sterile recalled | Merz North America | Device Malfunction | 48 states |
| Device | CLASS II | Prolaryn Injectable Implant 1.0 cc Gel recalled by Merz North America | Merz North America | Other | Nationwide |
| Device | CLASS II | Radiesse (+) Lidocaine Injectable Implant 1.5cc recalled | Merz North America | Other | Nationwide |
| Device | CLASS II | Prolaryn Plus Injectable Implant 1.0 cc Plus Calcium recalled | Merz North America | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |