FDA Medical Device Recall Statistics (2020-2026)
Comprehensive breakdown of FDA medical device recalls by year, classification, and device category. Updated monthly from FDA Enforcement Reports.
RECALLS BY YEAR AND CLASS
| Year | Class I | Class II | Class III | Total |
|---|---|---|---|---|
| 2020 | 72 | 540 | 234 | 846 |
| 2021 | 68 | 498 | 201 | 767 |
| 2022 | 81 | 523 | 189 | 793 |
| 2023 | 75 | 561 | 215 | 851 |
| 2024 | 84 | 579 | 198 | 861 |
| 2025 | 91 | 612 | 187 | 890 |
| 2026* | 45 | 298 | 92 | 435 |
* 2026 is partial year data through May 2026.
TOP RECALLED DEVICE CATEGORIES (2020-2026)
| Category | Recalls | Share |
|---|---|---|
| Cardiovascular Devices | 892 | 16.4% |
| In Vitro Diagnostics | 734 | 13.5% |
| Orthopedic Devices | 612 | 11.2% |
| General Hospital Devices | 548 | 10.1% |
| Radiological Devices | 423 | 7.8% |
| Neurological Devices | 389 | 7.1% |
| Gastroenterology/Urology | 312 | 5.7% |
| Ophthalmic Devices | 287 | 5.3% |
RECALL CLASSIFICATION EXPLAINED
Most serious. Reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death.
Use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
Use of or exposure to the product is not likely to cause adverse health consequences.
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Start Free MonitoringData compiled from FDA Enforcement Reports. Last updated May 2026.