Medical Device Statistics

Data and trends from 39,539 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
1Other25,691
2Sterility Issues5,714
3Labeling Errors3,104
4Software Issues1,864
5Calibration / Accuracy697
6Packaging Issues610
7Battery Issues543
8Contamination485
9Electrical Failure416
10Manufacturing Defect360
11cGMP Deviations6

Top Recalling Firms

Companies with the most FDA device recall actions.

#FirmRecalls
1Zimmer Biomet, Inc.875
2MEDLINE INDUSTRIES, LP - Northfield812
3Customed, Inc682
4Siemens Medical Solutions USA, Inc623
5Boston Scientific Corporation619
6ICU Medical, Inc.594
7GE Healthcare, LLC474
8Medline Industries, LP460
9Siemens Healthcare Diagnostics, Inc.456
10Zimmer, Inc.444
11Arrow International Inc431
12Olympus Corporation of the Americas408
13Baxter Healthcare Corporation375
14Biomerieux Inc369
15Covidien LLC334

Recalls by State

States where recalling firms are located.

#StateRecalls
1California4,622
2Massachusetts3,451
3Illinois3,207
4Pennsylvania2,944
5Indiana2,555
6N/A2,092
7New Jersey2,060
8Minnesota1,652
9Florida1,513
10New York1,394
11Ohio1,072
12Wisconsin954
13Michigan952
14Missouri930
15Puerto Rico813
16Texas801
17North Carolina763
18Tennessee746
19Connecticut710
20Georgia703

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.