Medical Device Statistics
Data and trends from 38,428 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 | 24,900 |
| 2 | Sterility Issues | 5,531 |
| 3 | Labeling Errors | 3,044 |
| 4 | Software Issues | 1,840 |
| 5 | Calibration / Accuracy | 693 |
| 6 | Packaging Issues | 608 |
| 7 | Battery Issues | 533 |
| 8 | Contamination | 478 |
| 9 | Electrical Failure | 406 |
| 10 | Manufacturing Defect | 340 |
| 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 | 615 |
| 5 | Boston Scientific Corporation | 601 |
| 6 | ICU Medical, Inc. | 590 |
| 7 | GE Healthcare, LLC | 474 |
| 8 | Siemens Healthcare Diagnostics, Inc. | 452 |
| 9 | Zimmer, Inc. | 437 |
| 10 | Arrow International Inc | 431 |
| 11 | Olympus Corporation of the Americas | 378 |
| 12 | Biomerieux Inc | 368 |
| 13 | Baxter Healthcare Corporation | 367 |
| 14 | Covidien LLC | 329 |
| 15 | Windstone Medical Packaging, Inc. | 315 |
About This Data
All medical device recall data comes from the U.S. FDA through the openFDA enforcement database. Our database contains 38,428 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 3,415 Class I, 34,001 Class II, and 1,011 Class III.