Sedgwick’s latest report shows fewer medical device recall events in Q1 2026, while sterility-related recalls drove the majority of impacted units.
Medical device recall events decreased 13.1% in the first quarter of 2026, falling from 252 events in the previous quarter to 219, according to the latest Sedgwick Product Safety and Recall Index report.
The number of units recalled also saw a significant decline of 55.7%, dropping to 146.63 million units from the 331.08 million units recorded in the fourth quarter of 2025.
Despite the quarterly decrease, unit volumes remain above the five-year quarterly average of 112.75 million units. Device failure was the leading cause of recalls by event, accounting for 41 incidents, followed by software and mislabeling with 24 events each. Sterility issues were responsible for the highest volume of impacted units, totaling 86.35 million, which was primarily driven by a single recall of 86.07 million convenience kits, the report states.
Regulatory Updates and Recall Process Challenges
The healthcare technology sector also saw the implementation of the updated Quality Management System Regulation (QMSR) on Feb 2, 2026. This mandatory regulation harmonizes US Food and Drug Administration (FDA) requirements with international standards by incorporating ISO 13485:2016. The update shifts the focus of inspections toward management responsibility and risk-based decision-making. As part of this transition, the FDA has replaced the Quality System Inspection Technique with a new process that allows for pre-inspection reviews of a firm’s compliance history, management oversight, supplier controls, and internal audits.
In addition to regulatory updates, a December 2025 report from the US Government Accountability Office (GAO) highlights challenges in the FDA device recall process. The GAO found that the FDA missed its own three-month termination target for recalls 74% of the time over the last five fiscal years. Staffing constraints have reportedly reduced oversight activity, including in-person audit checks and the review of recall status reports.
“A manufacturer’s recall program needs to be built to withstand scrutiny at any time, not only when the agency has capacity to apply it,” writes Rebecca Crane, partner at Crane Medtech Partners, in the report. The GAO report suggests that manufacturers must ensure their recall strategies stand on their own rationale, as the agency has less bandwidth to provide timely guidance on voluntary recall strategy or scope.
The FDA also issued updated guidance for low-risk general wellness products in January 2026. This category includes wearables that track sleep, activity, and nutrition. Under the new guidance, the agency does not intend to examine these products to determine if they qualify as medical devices in the US, provided they are non-invasive and not intended to treat or diagnose specific conditions. Current FDA administrators want to ease regulation to ensure patients have access to products that leverage new technologies, according to analysis from Arnold and Porter in the report.
Manufacturers are encouraged to review legacy quality practices and align documentation with the new QMSR principles.
