Merz North America, Inc. FDA Record
Merz North America, Inc. has 5 FDA recalls, 20 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Merz North America, Inc." is on file.
- Latest recall
- Z-0401-2021 · Class II · Sep 30, 2020
- Latest inspection
- Oct 28, 2025 · NAI
- Latest 510(k)
- Nov 29, 2017
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 5 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 20 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 1 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0401-2021 | Class II | COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical… | Sep 30, 2020 |
| Z-2607-2016 | Class II | Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics… | May 20, 2016 |
| Z-0366-2016 | Class II | Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal… | Oct 26, 2015 |
| Z-0367-2016 | Class II | PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in… | Oct 26, 2015 |
| Z-0368-2016 | Class II | PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant… | Oct 26, 2015 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 28, 2025 | Raleigh, NC | Devices | No Action Indicated (NAI) | 1012187 |
| Jan 3, 2024 | Sturtevant, WI | Devices | No Action Indicated (NAI) | 3013840437 |
| Jun 22, 2023 | Raleigh, NC | Devices | No Action Indicated (NAI) | 1012187 |
| Sep 18, 2019 | Raleigh, NC | Drugs | No Action Indicated (NAI) | 1012187 |
| Jul 26, 2018 | Raleigh, NC | Devices | Voluntary Action Indicated (VAI) | 1012187 |
| Aug 7, 2015 | Raleigh, NC | Drugs | No Action Indicated (NAI) | 1012187 |
| Mar 31, 2015 | San Mateo, CA | Devices | No Action Indicated (NAI) | 3011234890 |
| Jan 26, 2015 | Raleigh, NC | Drugs | No Action Indicated (NAI) | 1012187 |
| Sep 2, 2014 | Franksville, WI | Devices | No Action Indicated (NAI) | 3003407669 |
| Aug 15, 2014 | Raleigh, NC | Devices | No Action Indicated (NAI) | 1012187 |
| Apr 19, 2013 | Sturtevant, WI | Devices | No Action Indicated (NAI) | 3013840437 |
| Apr 19, 2013 | Franksville, WI | Devices | No Action Indicated (NAI) | 3003407669 |
| Jul 31, 2012 | Raleigh, NC | Devices | No Action Indicated (NAI) | 1012187 |
| Jul 21, 2011 | Raleigh, NC | Devices | Voluntary Action Indicated (VAI) | 1012187 |
| Apr 8, 2011 | Franksville, WI | Devices | Voluntary Action Indicated (VAI) | 3003407669 |
| Dec 23, 2010 | Franksville, WI | Devices | Voluntary Action Indicated (VAI) | 3003407669 |
| Sep 29, 2010 | Raleigh, NC | Drugs | No Action Indicated (NAI) | 1012187 |
| May 25, 2010 | Raleigh, NC | Devices | No Action Indicated (NAI) | 1012187 |
| Jan 15, 2010 | Raleigh, NC | Devices | No Action Indicated (NAI) | 1012187 |
| Nov 24, 2009 | Raleigh, NC | Devices | Official Action Indicated (OAI) | 1012187 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1012187 | Raleigh, NC | 13 | Oct 28, 2025 |
| FEI 3013840437 | Sturtevant, WI | 2 | Jan 3, 2024 |
| FEI 3011234890 | San Mateo, CA | 1 | Mar 31, 2015 |
| FEI 3003407669 | Franksville, WI | 4 | Sep 2, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K172689 | DESCRIBE PFD Patch | Nov 29, 2017 |
Merz North America, Inc. and the FDA: common questions
Has Merz North America, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Merz North America, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Merz North America, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Merz North America, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Merz North America, Inc.?
The most recent FDA inspection on file ended Oct 28, 2025 at Raleigh, NC and was classified NAI. FDA has 20 inspections of Merz North America, Inc. on file, 1 of them classified OAI (official action indicated).
Has Merz North America, Inc. had an FDA recall?
Yes. Merz North America, Inc. has 5 FDA recalls on record. The most recent started Sep 30, 2020.
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