Medical Device Recall Statistics: 2026 Report

When a company finds that one of its medical devices is defective or could put patients at risk, it usually fixes the device where it is used or pulls it from hospitals and stores, then tells the FDA. The agency calls either action a recall. A recall can mean a software update, new instructions for clinicians, or removal of a product, and one recall often covers many catalog numbers. The FDA then rates each recall by risk. Class I means a reasonable chance the product will cause serious health problems or death, Class II covers temporary or reversible problems, and Class III covers products unlikely to cause harm. Reporters, hospital supply chain teams, and medtech quality leaders keep asking how many devices are recalled each year and how many of those recalls are serious. The answer depends on whether you count recalled products or recall events, so we counted both.

Our analysts pulled every medical device record in the FDA's weekly Enforcement Reports from January 1, 2016, through October 28, 2026, a total of 31,337 product records. We grouped those records into 10,894 recall events using the FDA's event number and counted each event at the most serious class assigned to any of its products. We also pulled 8,378 records from the FDA's device recall database for recalls that began from January 2024 through October 2026, which add the start date, the root cause the FDA assigned, and the medical specialty of each product. We grouped recalling firms under their parent companies.

In the following sections, we compare recall volume by year, recall events by FDA risk class, recalls by start month, root causes, medical specialties, and the companies with the most recall events in 2026.

How Many Medical Device Recalls the FDA Reports Each Year

The FDA publishes each classified recall in its weekly Enforcement Report, with a separate entry for every recalled product. We counted those entries by report year and grouped them into recall events, since one event can list dozens or hundreds of products.

Source: Healthcare Industry Reviews analysis of FDA openFDA device enforcement reports, conducted November 2026. Records counted by FDA report date.

Source: Healthcare Industry Reviews analysis of FDA openFDA device enforcement reports, conducted November 2026.

Key Findings

• Recall events stayed between 835 (2023) and 1,289 (2018) a year from 2016 through 2025, while product records ranged from 2,192 (2022) to 3,757 (2018). Product counts swing more because a single event can list hundreds of products.
• 2024 had 3,394 product records, the most since 2018, and 1,034 events. Both fell in 2025, to 2,908 records and 972 events.
• A product count can make a year look like a recall surge when the number of separate problems barely changed. In 2026, Medline alone accounted for 524 of the 2,589 product records reported through October 28, so citing events alongside products gives readers the clearer measure of how many distinct problems the FDA handled.

How Serious Device Recalls Have Been by FDA Class

The FDA class tells hospitals and patients how much danger a recall involves, which matters more to most readers than the raw count. We counted each recall event once, at the most serious class the FDA gave any product in it, to see whether serious recalls make up a growing share.

Source: Healthcare Industry Reviews analysis of FDA openFDA device enforcement reports, conducted November 2026. One event without a class in 2024 is counted at the class of its other products.

Source: Healthcare Industry Reviews analysis of FDA openFDA device enforcement reports, conducted November 2026.

Key Findings

• Class I events rose from 46 in 2016, or 3.8% of events, to 135 in 2025, or 13.9%. Both the count and the share were the highest in the series.
• Class II recalls are still most of the total: 820 of 972 events in 2025 (84.4%). Class III events, the least serious, fell from 53 in 2016 to 17 in 2025.
• Through October 28, 2026, the FDA had reported 86 Class I events, 10.2% of the year's 847 events. A larger share of the recall notices hospitals receive now carries the FDA's highest risk rating, which asks clinical and supply teams to act on more urgent notices each year.

How Many Device Recalls Begin Each Month

The FDA's recall database records the date each company began its recall, which shows when problems came to light. We counted recall records by start month from January 2024 through September 2026 and totaled them by quarter.

Source: Healthcare Industry Reviews analysis of FDA openFDA device recall data, conducted November 2026. Counted by recall start date; October 2026 is excluded because it was incomplete.

Source: Healthcare Industry Reviews analysis of FDA openFDA device recall data, conducted November 2026.

Key Findings

• April 2024 had the most recall starts of any month in the period, with 389 records, and April 2025 had the fewest, with 145.
• Recalls that began in the first three quarters of 2026 totaled 2,239 records, compared with 2,020 in the same months of 2025. The second quarter of 2025 was the low point, at 587.
• Recall records enter the database once the FDA classifies them, so counts for the most recent months will grow. September 2026, at 178 records, is the month most likely to be revised upward as the FDA finishes classifying recalls that began then.

Why Medical Devices Are Recalled

The FDA assigns each recall a root cause category after reviewing the company's own investigation, from manufacturing slips to flaws in how a device or its software was designed. We tallied those categories for recalls that began in 2024 and 2025.

Source: Healthcare Industry Reviews analysis of FDA openFDA device recall data, conducted November 2026. Shares use all 2,839 recall records that began in 2025.

Source: Healthcare Industry Reviews analysis of FDA openFDA device recall data, conducted November 2026.

Key Findings

• The largest single category in 2025, with 688 records (24.2%), was recalls the FDA had classified while the company was still investigating the cause. Process control, meaning problems in how a device was made, followed with 516 records (18.2%).
• Device design accounted for 433 records in 2025, up from 285 in 2024. Together with software design and package design, design-related causes covered 649 records in 2025, compared with 445 in 2024.
• Recalls for selling a device without the required FDA marketing application fell from 291 records in 2024 to 159 in 2025. Design causes are now a larger part of the recall total, which points quality teams toward design review and software testing as well as factory controls.

Which Medical Specialties Have the Most Device Recalls

Every recalled product carries an FDA product code that ties it to a medical specialty panel, such as radiology or cardiovascular. We counted recall records by that panel for recalls that began in 2024 and 2025 to show which kinds of devices are recalled most often.

Source: Healthcare Industry Reviews analysis of FDA openFDA device recall data, conducted November 2026. Top 10 specialties by 2025 records; records without a specialty are excluded.

Source: Healthcare Industry Reviews analysis of FDA openFDA device recall data, conducted November 2026.

Key Findings

• Radiology devices, such as imaging systems and their software, had 586 recall records in 2025, the most of any specialty and up from 334 in 2024.
• General and plastic surgery products fell from 608 records in 2024, the top specialty that year, to 227 in 2025. Cardiovascular devices fell from 482 to 283.
• Radiology and general hospital devices, a panel that covers beds, infusion supplies, and other everyday equipment, made up 934 of the 2,839 recall records that began in 2025, or 32.9%. For hospital imaging and nursing departments, that is where most new recall notices landed.

Which Companies Had the Most Device Recall Events in 2026

Large manufacturers and companies that assemble procedure kits appear often in Enforcement Reports because they sell thousands of products. We grouped each recalling firm under its parent company and counted 2026 recall events, with 2025 events for comparison.

Source: Healthcare Industry Reviews analysis of FDA openFDA device enforcement reports, conducted November 2026. 2026 covers reports from January 1 to October 28, 2026.

Source: Healthcare Industry Reviews analysis of FDA openFDA device enforcement reports, conducted November 2026.

Key Findings

• Medline had 59 recall events and 524 product records in 2026 through October 28, up from 45 events in all of 2025. Eleven of its 2026 events were Class I.
• Philips (44 events) and Medtronic (32) followed Medline. Abiomed was outside the top 10 with 12 events, but 10 of them were Class I, second only to Medline's 11.
• AVID Medical went from 4 events in 2025 to 17 in 2026. The 2026 Enforcement Reports show AVID Medical, Medline, and other kit makers recalling procedure kits because a component inside them, such as a BD ChloraPrep skin prep applicator or a Huons anesthetic injection, had a problem at its own maker, so one component problem can set off several kit recalls.

What Device Recall Counts Mean for Hospitals and Patients

Most device recalls do not take a product away from patients. They ask hospitals to update software, follow new instructions, or check a device, and the FDA has rarely needed to order a company to recall a device. Still, the number of Class I events, the recalls with a reasonable chance of serious harm or death, has grown every year since 2022 and reached 135 in 2025.

The causes are shifting as well. Design and software problems made up a larger share of 2025 recalls than of 2024 recalls, and imaging equipment overtook surgical supplies as the specialty with the most recall records. Kit recalls that follow a single component recall add to the totals for companies that assemble procedure trays.

So if you are citing how many medical devices were recalled, give the event count with its report year and the Class I share, because product counts can rise sharply on one large recall while the number of separate problems stays close to the year before.

Data Collection and Methodology

We downloaded all medical device records from the openFDA device enforcement endpoint with report dates from January 1, 2016, through October 28, 2026 (31,337 records; the dataset was last updated October 28, 2026), on November 9, 2026. Each record is one recalled product as listed in the FDA's weekly Enforcement Report. We grouped records into recall events by the FDA event number, counted each event once per report year, and assigned it the most serious class among its products. No event appeared in more than one report year. One 2024 record listed as not yet classified belongs to an event with other classified products.

Monthly volume, root causes, and medical specialties come from the openFDA device recall endpoint (dataset last updated November 5, 2026), downloaded the same day: 3,284 records with recall start dates in 2024, 2,839 in 2025, and 2,255 from January 1 to October 19, 2026. October 2026 is excluded from the monthly series because it was incomplete. Medical specialty is the FDA review panel linked to each product code; records with no linked panel are excluded from that table. Root cause categories are the FDA's own labels.

For company counts, we grouped recalling firm names under their parent company (for example, Philips Medical Systems Nederland, Philips North America, and Philips Ultrasound under Philips; CareFusion, C.R. Bard, Bard Access Systems, and Becton Dickinson under BD; Covidien and Medtronic units under Medtronic; Datex-Ohmeda and GE Medical Systems units under GE HealthCare). We calculated products, differences, and ratios from the published values.

Sources

1. Healthcare Industry Reviews analysis of FDA medical device enforcement report records (2016 to October 28, 2026) and FDA device recall database records (January 2024 to October 2026), conducted November 2026.
2. U.S. Food and Drug Administration. openFDA Device Recall Enforcement Reports. Data last updated October 28, 2026.
3. U.S. Food and Drug Administration. openFDA Device Recalls. Data last updated November 5, 2026.
4. U.S. Food and Drug Administration. What is a Medical Device Recall?
5. U.S. Food and Drug Administration. Medical Device Recalls and Early Alerts. Accessed November 9, 2026.