Medical Device Statistics

Data and trends from 39,885 FDA medical device recalls spanning 1930 to 2026.

0Total Recalls
0Class I (Most Serious)
0Class II
0Voluntary Recalls

Device Recalls by Year

Number of FDA medical device recall enforcement actions per year.

Top Recall Reasons

Most common reasons for FDA device recalls.

#ReasonRecalls
1Other25,898
2Sterility Issues5,749
3Labeling Errors3,142
4Software Issues1,886
5Calibration / Accuracy709
6Packaging Issues620
7Battery Issues544
8Contamination500
9Electrical Failure421
10Manufacturing Defect361
11cGMP Deviations6

Top Recalling Firms

Companies with the most FDA device recall actions.

#FirmRecalls
1Zimmer Biomet, Inc.875
2MEDLINE INDUSTRIES, LP - Northfield812
3Customed, Inc682
4Boston Scientific Corporation636
5Siemens Medical Solutions USA, Inc623
6ICU Medical, Inc.596
7Medline Industries, LP503
8GE Healthcare, LLC474
9Siemens Healthcare Diagnostics, Inc.461
10Zimmer, Inc.444
11Arrow International Inc431
12Olympus Corporation of the Americas415
13Baxter Healthcare Corporation376
14Biomerieux Inc369
15Windstone Medical Packaging, Inc.336

Recalls by State

States where recalling firms are located.

#StateRecalls
1California4,653
2Massachusetts3,494
3Illinois3,263
4Pennsylvania2,968
5Indiana2,560
6N/A2,104
7New Jersey2,061
8Minnesota1,674
9Florida1,516
10New York1,398
11Ohio1,092
12Wisconsin966
13Michigan954
14Missouri930
15Texas816
16Puerto Rico813
17North Carolina768
18Tennessee749
19Connecticut717
20Georgia706

About This Data

All medical device recall data comes from the U.S. FDA through the openFDA enforcement database. Our database contains 39,885 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 3,629 Class I, 35,226 Class II, and 1,029 Class III.