Sedgwick Index Finds Fewer Medical Device Recalls in 2025 but More Defective Units

Medical device makers recorded fewer recalls in 2025 than the year before, but the number of defective device units swept up in recalls increased, according to an annual recall index released on February 19 by Sedgwick, a risk and claims administration company.

Sedgwick's 2026 State of the Nation U.S. Product Safety and Recall Index tracks recalls across five sectors: automotive, consumer products, food and drink, pharmaceuticals and medical devices. Across all five, it counted 3,295 recalls in 2025, up slightly from 3,232 in 2024. Only three years in the past decade recorded a higher number, the company said.

Devices diverge from the overall trend

The medical device and automotive industries both saw modest declines in recall activity, of 8% and 6% respectively, while consumer products, food and drink, and pharmaceuticals all recorded more recalls than in 2024, according to Sedgwick. Consumer products posted the industry's highest annual total in more than a decade.

Defective units moved differently. Across all five industries they rose 26%, from 681 million in 2024 to 858 million in 2025. The pharmaceutical, food and drink, and medical device sectors all recorded year-over-year increases in defective units, while consumer products and automotive declined, the company said. Defective automotive units fell to an 11-year low.

The release did not break out the device sector's unit count. Sedgwick publishes the index quarterly; the State of the Nation edition reviews the full year and the fourth quarter.

Regulators and recall oversight

Sedgwick said 2025 brought considerable regulatory change as the Trump administration set new priorities, using tariffs and incentives to encourage companies to move production to the US or expand existing operations. Regulators across industries reminded companies of their recall responsibilities, and in some cases imposed heavy fines for delays in reporting product defects, the company said. It expects trade and tariffs, domestic manufacturing and deregulation to remain areas of focus in 2026.

"Regulators across industries are looking to increase oversight, improve the effectiveness of product recalls, and expand post market responsibilities beyond just the manufacturer," said Chris Harvey, a senior vice president at Sedgwick.

The FDA's own capacity to oversee device recalls has drawn scrutiny. In a report released in December, the Government Accountability Office found that the agency oversaw the recall of 3,934 medical devices in fiscal years 2020 through 2024, all of them voluntarily recalled by manufacturers. Insufficient staff limit the FDA's ability to conduct oversight activities, according to officials quoted by GAO, and the agency could not meet its three-month goal for terminating recalls during that period because of resource constraints.

GAO recommended that the Department of Health and Human Services work with the FDA on workforce planning for device recalls and assess whether the agency needs more authority over how manufacturers carry out recalls. HHS agreed with the first recommendation and said it was considering the second, according to the report.