FDA links Abbott CGM sensor problems to 860 serious injuries, flags more reprocessed-device recalls

The U.S. Food and Drug Administration said on Feb. 25 that problems with Abbott-related continuous glucose monitor sensors are now associated with 860 serious injuries and that its review has identified additional recalls involving reprocessed medical devices. The update broadened a regulatory inquiry that began with sporadic device malfunction reports and is now focusing on reuse and reprocessing practices that may affect sensor performance.

The FDA’s disclosure did not include new company statements but cited device incident reports and recall notices that regulators and industry groups have been tracking this year. Agency officials said their analysis links adverse event reports to sensors that had been reprocessed after initial use, and they documented follow-on recalls of other reprocessed devices by health-care facilities and third-party vendors. The agency characterized the situation as an active safety review and told providers and patients to consult manufacturers and device labeling for guidance.

Reprocessing generally refers to cleaning, sterilizing and testing a single-use medical device so it can be used again. Hospitals and third-party reprocessing companies perform such work on a range of products to lower costs or maintain supply. Regulators have long warned that reprocessing can change a device’s performance characteristics, and the FDA’s latest update signals that those concerns can translate into measurable patient harm when applied to sensitive, patient-worn electronics like CGM sensors.

Continuous glucose monitors are integrated into insulin dosing and diabetes management workflows; inaccurate readings can lead clinicians or patients to underdose or overdose insulin. The FDA’s count of 860 serious injuries raises the immediate operational stakes for diabetes clinics, infusion centers and home-care programs that reprocess or accept reprocessed sensors. Providers now face decisions about inventory, device tracking, and whether to suspend use of reprocessed lots while the agency’s review continues.

For Abbott, the regulatory spotlight threatens both reputational and financial costs. Abbott’s CGM systems are widely used across ambulatory and hospital settings, and increased recalls or mandated changes to labeling and distribution could force hospitals to change procurement practices and absorb replacement costs. Insurers and health systems may accelerate moves away from reused sensors to new single-use supplies, raising short-term spending on diabetes supplies even as manufacturers and payers weigh longer-term policy changes.

Beyond Abbott, the FDA’s note that additional reprocessed-device recalls were flagged suggests broader industrial and regulatory ripples. Third-party reprocessors and health systems that rely on cost savings from reuse now face potential liability, tighter documentation requirements, and more frequent inspections. The incident also underscores a policy trade-off for regulators: balancing device availability and cost containment against patient safety when single-use items are reused.

The FDA said its review is ongoing and that it will update the public and health-care partners as further evidence accumulates. For now, patients using Abbott-related CGM systems and clinics that reprocess sensors confront an immediate operational choice: verify device provenance and recall status and consult manufacturers for next steps as regulators close in on the root causes of the reported injuries.