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Abbott Recalls 3 Million Libre 3 Sensors After 7 Deaths, FDA Class I Alert

Abbott Recalls 3 Million Libre 3 Sensors After 7 Deaths, FDA Class I Alert
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A recall of millions of Abbott continuous glucose monitor sensors tied to at least seven deaths and 860 serious injuries worldwide has left diabetes patients and caregivers scrambling to verify the safety of devices many rely on around the clock independent +1. U.S. regulators classified the action involving certain FreeStyle Libre 3 and Libre 3 Plus sensors as a Class I recall, the most serious category, warning users to stop using affected sensors immediately nbcnews +1.

Abbott first issued an “Urgent Medical Device Correction” on November 24, 2025, after internal testing showed some sensors could give falsely low glucose readings, potentially prompting patients to skip insulin or consume unnecessary sugar npr. The company said the problem was tied to one production line affecting about 3 million sensors in the U.S., roughly half of which it estimated had already been used or expired npr. As of January 7, 2026, Abbott and the FDA had linked the issue to seven deaths and 860 serious injuries globally, including seizures, loss of consciousness and hospitalizations independent +1.

How the Recall Unfolded — And Who Is Affected

The FDA issued an early public alert on December 2, 2025, and later upgraded the case to a Class I recall in early February, stressing that continued use of the affected sensors could cause serious injury or death nbcnews +1. Affected devices include specific lot numbers of FreeStyle Libre 3 and Libre 3 Plus sensors; the recall does not cover the readers, smartphone apps, or other Libre product lines nbcnews +1.

Patients are being directed to check sensor serial numbers on a dedicated Abbott website and to request free replacements if their devices are flagged nbcnews +1. Abbott said it had “identified and resolved the cause of the issue” and did not expect major supply disruptions, as manufacturing has continued on lines not implicated in the defect npr. Clinicians, meanwhile, are urging patients to verify readings with traditional blood glucose meters whenever symptoms don’t match what the sensor shows fiercebiotech.

Mounting Scrutiny: FDA Warning Letter and Lawsuits

Beyond the immediate recall, Abbott is facing heightened regulatory and legal scrutiny. After inspecting the company’s diabetes-care facility in Alameda, California, the FDA issued a warning letter dated January 23, 2026, faulting Abbott for relying on component-level testing and failing to ensure that finished, sterilized sensors met accuracy standards at release cbsnews. The agency said these quality-system lapses demanded corrective action cbsnews.

Families and patients have begun filing lawsuits, including a wrongful-death case in Oakland that alleges a Libre 3 Plus sensor’s false low reading contributed to a 68‑year‑old man’s death people. Class-action filings accuse Abbott of delaying disclosure of the defect and inadequately warning users of the risks hoodline. An Abbott spokesperson told NBC News the company was “deeply saddened” by reports of deaths and injuries but maintains that it acted to correct the issue and replace affected sensors fiercebiotech.

The Bigger Picture

The recall highlighted the double-edged nature of continuous glucose monitors: devices that have transformed diabetes care by reducing finger sticks can become life-threatening when readings are wrong. With millions of sensors involved and legal and regulatory actions still unfolding, the case is shaping the debate over how tightly manufacturers and regulators should monitor high-dependence medical technologies that patients trust to make rapid, life-or-death dosing decisions.