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.
METHODOLOGY & HOW TO CITE
Scope: FDA medical device recalls summarized from public Enforcement Report listings by fiscal calendar year and FDA recall class (I / II / III). Category shares are aggregated from product codes / industry labels in public records.
Limitations: Counts may differ from other analyses depending on firm-initiated vs FDA-classified actions, duplicate event consolidation, and mid-year cutoffs. 2026 is partial-year. Always verify critical decisions against primary FDA sources.
Suggested citation: MedFlux. “FDA Medical Device Recall Statistics (2020–2026).” https://www.medflux.live/data/fda-recall-stats (accessed YYYY-MM-DD).
Related guides: Monitor FDA recalls · Recall classification · MAUDE database guide · Free recall lookup
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Start Free MonitoringData compiled from FDA Enforcement Reports. Last updated May 2026.