Medical device recalls hit a four-year high in 2024. Here’s why

Medical device recall events in 2024 reached their highest level since 2020 and more than 10% of them involved the most serious type of recall.

There were 1,048 medical device recalls in 2024, an increase of almost 25% from the 840 recalls that occurred in 2023, according to the Food and Drug Administration. Class I recalls, the most serious type, accounted for 10.9% of recalls.

On Friday, there was another Class I recall by the agency, of Boston Scientific's Accolade pacemaker. The FDA, which approves devices for use and notifies the public about the safety events, said there were 832 reported injuries and two fatalities linked to the device.

Related: FDA labels Boston Scientific pacemaker recall most serious

The FDA intensified its efforts to share recall information more quickly last year with the launch of a pilot program. A spokesperson at the agency said that contributed to the increase in recalls.

Here's what to know about the recalls.

How do medical device recalls work?

A medical device is recalled when it fails to meet FDA standards or poses a health risk. Medical device companies typically will recall a product voluntarily, but the FDA may issue a mandatory recall if a company refuses to do it and the product poses a major health risk.

A recall is either a correction, which addresses a problem with a medical device, or a removal, which involves removing the device from the market.

How the FDA classifies recalls depends on the level of risk. Class I, the most serious type, involves devices that have a “reasonable chance” of causing serious health problems or death, according to the agency.

Class II recalls are for products that might lead to temporary or reversible health problems or are associated with a slight chance of serious health problems or death. Class III recalls are unlikely to result in health issues or injury.

In 2024, Class I recalls reached 114, the most recorded since at least 2012.

Why are there more recalls?

It’s largely because the agency is working to improve compliance with reporting and recall requirements, a FDA spokesperson wrote in an email.

“A large portion of the increase is due to a higher number of recalls from a small number of manufacturers subject to inspections and/or other actions,” the spokesperson wrote. “Additionally, manufacturers are increasingly reporting problems and fixing them due to a continued, concerted effort by the FDA to drive greater device safety.”

The FDA’s Center for Devices and Radiological Health launched a pilot program in November to more quickly share information on recalls that the agency considers high risk by issuing what it refers to as "early alerts." Those could include when companies take products off the market, make corrections to products or update instructions for using products that pose potential high safety risks.

The agency is only providing early alerts for cardiovascular, gastrorenal, general hospital, obstetrics and gynecology and urology product recalls and corrections. There have been eight early alerts since the pilot program started.

Recent firings of staff at the center could lead to delays in device approvals and mean fewer employees are available to support the efforts to improve compliance.

How are things going this year?

There have been 147 medical device recall events and 20 of them, or 13.6%, were Class I.

Philips recalled its remote cardiac monitoring software Dec. 18, and the FDA issued a notice Jan. 14 deeming it Class I. The recall, associated with a reported 109 injuries and two deaths, is a correction and Philips advised its clinician customers to visit the Philips Prescriber Response Site to determine which patients were affected and may need their data reprocessed. The company found the software was not properly handling certain electrocardiogram readings, potentially leading to missing information in reports or missed reports.

Philips issued a recall Jan. 13, that the FDA labeled Class I, of certain Allura Xper FD series and Allura Xper OR Table series because of the possibility of patients falling from the table.

Dexcom, Medline Industries, Stryker, Cardinal Health, Boston Scientific, Becton Dickinson and Intuitive Surgical are a few of the other medtech companies that issued recalls this year.