Device reports by FDA panel, 12 months to September 2026
What a report is
A report is not proof that a medicine or a device was the cause of an event.
FDA says:
Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
The answer in sentences
In the 12 months to September 2026, the panel with the most device reports was Clinical Chemistry: 1,093,138 reports.
Of the panels with 5,000 reports or more in the 12 months before, the largest change was in General Hospital: +81.5%.
FDA received 3,444,740 device reports in the 12 months to September 2026 and 2,846,489 in the 12 months before.
Data version
Drug data: openFDA FAERS release of 12 Oct 2026. Reports received through 30 Jun 2026.
Device data: openFDA MAUDE release of 14 Oct 2026. Reports received through 30 Sep 2026.
Panels by reports
The table has every panel of the 1,072 device types that have a page. A percent change needs 5,000 reports in the 12 months before.
FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Panel | Device types | Reports, 12 months to September 2026 | Reports, 12 months before | Change |
|---|---|---|---|---|
| Clinical Chemistry | 52 | 1,093,138 | 746,720 | +46.4% |
| Dental | 44 | 753,445 | 781,957 | -3.6% |
| Unknown | 148 | 499,935 | 469,208 | +6.5% |
| General Hospital | 84 | 274,006 | 150,962 | +81.5% |
| Gastroenterology, Urology | 125 | 230,656 | 147,850 | +56.0% |
| Anesthesiology | 54 | 170,461 | 154,830 | +10.1% |
| General, Plastic Surgery | 128 | 119,389 | 111,243 | +7.3% |
| Cardiovascular | 116 | 112,780 | 110,458 | +2.1% |
| Orthopedic | 108 | 74,011 | 76,025 | -2.6% |
| Neurology | 30 | 18,479 | 16,648 | +11.0% |
| Physical Medicine | 29 | 18,390 | 1,952 | n/a |
| Ear, Nose, Throat | 14 | 17,485 | 12,663 | +38.1% |
| Ophthalmic | 31 | 16,563 | 17,001 | -2.6% |
| Radiology | 25 | 16,288 | 19,277 | -15.5% |
| Obstetrics/Gynecology | 23 | 10,735 | 9,612 | +11.7% |
| Microbiology | 27 | 3,854 | 9,146 | -57.9% |
| Hematology | 19 | 1,602 | 1,274 | n/a |
| Clinical Toxicology | 6 | 395 | 63 | n/a |
| Pathology | 4 | 393 | 237 | n/a |
| Immunology | 5 | 181 | 159 | n/a |
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Device classes
FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Device class | Device types | Reports, 12 months to September 2026 | Reports, 12 months before | Change |
|---|---|---|---|---|
| Class 1 | 234 | 138,032 | 101,960 | +35.4% |
| Class 2 | 648 | 2,681,256 | 2,148,673 | +24.8% |
| Class 3 | 161 | 605,206 | 577,525 | +4.8% |
| Other or not given | 29 | 7,692 | 9,127 | -15.7% |
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
How the figures were made
FDA gives each product code a panel and a device class in its device classification. The site takes both from that file. A product code that FDA classifies with no panel is in the row Unknown.
A report can have more than one product code and counts once for each code. The counts of the panels add to more than the number of reports.
The table has the device types that have a page: 300 reports or more with the product code. Device types with a page are listed in the directory of devices.
A count is a count of reports, not of events or of patients, and it is not a rate.
A program makes this page from the openFDA files with fixed sentence rules. See how the site counts reports and the data sources.
In earlier editions
This table is in the edition of October 2026, the first edition. Each month adds an edition that keeps the first rows of the table as they were.