Mueller Sports Medicine, Inc FDA Record
- Latest inspection NAI · Apr 3, 2025
- No warning letters matched by name
Mueller Sports Medicine, Inc has 1 FDA recall, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mueller Sports Medicine, Inc" is on file.
- Latest recall
- Z-2475-2020 · Class II · Jun 18, 2020
- Latest inspection
- Apr 3, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 7 | 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
Mueller Sports Medicine, Inc: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2475-2020 | Class II | Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box | Jun 18, 2020 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 3, 2025 | Prairie Du Sac, WI | Devices | No Action Indicated (NAI) | 2110420 |
| Mar 11, 2019 | Prairie Du Sac, WI | Food/Cosmetics | No Action Indicated (NAI) | 2110420 |
| Apr 20, 2016 | Prairie Du Sac, WI | Drugs | No Action Indicated (NAI) | 2110420 |
| Dec 5, 2013 | Prairie Du Sac, WI | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2110420 |
| Sep 6, 2012 | Prairie Du Sac, WI | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2110420 |
| Apr 21, 2011 | Prairie Du Sac, WI | Drugs | No Action Indicated (NAI) | 2110420 |
| Apr 23, 2009 | Prairie Du Sac, WI | Drugs | No Action Indicated (NAI) | 2110420 |
- 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 2110420 | Prairie Du Sac, WI | 7 | Apr 3, 2025 |
Mueller Sports Medicine, Inc and the FDA: common questions
Has Mueller Sports Medicine, Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Mueller Sports Medicine, 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 Mueller Sports Medicine, Inc received an FDA Form 483?
FDA has not published a Form 483 for "Mueller Sports Medicine, Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Mueller Sports Medicine, Inc?
The most recent FDA inspection on file ended Apr 3, 2025 at Prairie Du Sac, WI and was classified NAI. FDA has 7 inspections of Mueller Sports Medicine, Inc on file.
Has Mueller Sports Medicine, Inc had an FDA recall?
Yes. Mueller Sports Medicine, Inc has 1 FDA recall on record. The most recent started Jun 18, 2020.
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