Medical Device Statistics
Data and trends from 39,539 FDA medical device recalls spanning 1930 to 2026.
Device Recalls by Year
Number of FDA medical device recall enforcement actions per year.
Top Recall Reasons
Most common reasons for FDA device recalls.
| # | Reason | Recalls |
|---|---|---|
| 1 | Other | 25,691 |
| 2 | Sterility Issues | 5,714 |
| 3 | Labeling Errors | 3,104 |
| 4 | Software Issues | 1,864 |
| 5 | Calibration / Accuracy | 697 |
| 6 | Packaging Issues | 610 |
| 7 | Battery Issues | 543 |
| 8 | Contamination | 485 |
| 9 | Electrical Failure | 416 |
| 10 | Manufacturing Defect | 360 |
| 11 | cGMP Deviations | 6 |
Top Recalling Firms
Companies with the most FDA device recall actions.
| # | Firm | Recalls |
|---|---|---|
| 1 | Zimmer Biomet, Inc. | 875 |
| 2 | MEDLINE INDUSTRIES, LP - Northfield | 812 |
| 3 | Customed, Inc | 682 |
| 4 | Siemens Medical Solutions USA, Inc | 623 |
| 5 | Boston Scientific Corporation | 619 |
| 6 | ICU Medical, Inc. | 594 |
| 7 | GE Healthcare, LLC | 474 |
| 8 | Medline Industries, LP | 460 |
| 9 | Siemens Healthcare Diagnostics, Inc. | 456 |
| 10 | Zimmer, Inc. | 444 |
| 11 | Arrow International Inc | 431 |
| 12 | Olympus Corporation of the Americas | 408 |
| 13 | Baxter Healthcare Corporation | 375 |
| 14 | Biomerieux Inc | 369 |
| 15 | Covidien LLC | 334 |
Recalls by State
States where recalling firms are located.
| # | State | Recalls |
|---|---|---|
| 1 | California | 4,622 |
| 2 | Massachusetts | 3,451 |
| 3 | Illinois | 3,207 |
| 4 | Pennsylvania | 2,944 |
| 5 | Indiana | 2,555 |
| 6 | N/A | 2,092 |
| 7 | New Jersey | 2,060 |
| 8 | Minnesota | 1,652 |
| 9 | Florida | 1,513 |
| 10 | New York | 1,394 |
| 11 | Ohio | 1,072 |
| 12 | Wisconsin | 954 |
| 13 | Michigan | 952 |
| 14 | Missouri | 930 |
| 15 | Puerto Rico | 813 |
| 16 | Texas | 801 |
| 17 | North Carolina | 763 |
| 18 | Tennessee | 746 |
| 19 | Connecticut | 710 |
| 20 | Georgia | 703 |
About This Data
All medical device recall data comes from the U.S. FDA through the openFDA enforcement database. Our database contains 39,539 device recall enforcement actions spanning 1930 to 2026.
Class I is the most serious, reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse effects. Class III is least serious, exposure not likely to cause harm. Our database contains 3,590 Class I, 34,923 Class II, and 1,025 Class III.