FreeStyle Libre 3 Recall Lawsuit

🔍 Confirmed Recalled Serial Numbers

Compare against the serial number on your sensor applicator, carton label, or inside your FreeStyle LibreLink app or reader:

Carbon buildup caused falsely low readings. Internal testing at Abbott identified that carbon accumulated during the manufacturing process on one specific production line, causing approximately 3 million sensors to report glucose levels significantly lower than a patient's actual blood sugar. This root cause was not immediately disclosed to patients or healthcare providers.

Prior 2024 recall ignored as a warning sign. In July 2024, Abbott had already issued a Class I recall for FreeStyle Libre 3 sensors that were reporting inaccurately high glucose readings — the opposite error. Lawsuits allege Abbott failed to address systemic quality control failures exposed by that earlier recall, which foreshadowed the 2025 crisis.

Delayed recall while injuries mounted. Despite internal knowledge of the defect, Abbott did not issue a medical device correction until November 24, 2025. By that time, 860+ serious injuries and 7 deaths had already been reported globally — including the November 17, 2025 death of 68-year-old Michael Leroy Ford of Alameda, California, whose sensor displayed a reading of 68 mg/dL when his actual blood glucose was significantly higher.

Deceptive "unsurpassed accuracy" marketing. Abbott marketed FreeStyle Libre 3 as the "world's smallest and most accurate 14-day glucose sensor" with "unsurpassed accuracy" and promoted it as a replacement for traditional finger-stick testing. Plaintiffs allege this made patients uniquely dependent on — and vulnerable to — inaccurate readings.

FDA finds corrective actions inadequate. In a January 23, 2026 Warning Letter, the FDA told Abbott its remediation efforts were insufficient. The agency found the devices were "adulterated," that Abbott's manufacturing methods were "not in conformity with current good manufacturing practice requirements," and that proposed future testing did not ensure the product would meet accuracy requirements — describing the violations as "symptomatic of serious problems" in Abbott's quality management systems.

📦 What to Keep and Preserve Right Now

If you or a loved one was injured while using a recalled sensor, preserve every piece of evidence you still have. Discarding your device destroys critical proof that could directly affect the value of your claim.

Do not delete your FreeStyle LibreLink app data. CGM app readings showing the falsely low glucose level at or before your injury are some of the most powerful causation evidence available.

Keep your sensor, packaging, and applicator — even if Abbott's instructions say to dispose of it. Store it in a sealed bag in a safe place and note the serial number.

Request and preserve all medical records from your ER visit, hospital stay, EMS response, or treating physician — including any records that document a discrepancy between your CGM reading and a fingerstick or lab test.

Save your purchase records — pharmacy receipts, insurance EOBs, or mail-order invoices that document when and where you obtained the sensors.

Save any recall notices you received from Abbott, CVS, your pharmacy, or your insurance company — these help establish you were using an affected device.

March 2026

No MDL Formed Yet — Consolidation Possible as Cases Grow

As of March 2026, plaintiffs' attorneys have not yet filed a motion to consolidate FreeStyle Libre 3 injury cases into a multidistrict litigation (MDL). Cases are currently proceeding as individual filings. Legal observers note that MDL consolidation is a possibility as the number of injury claimants grows. No settlements have been reached and no trial dates have been scheduled.

February 10, 2026

McCune Law Group Files First U.S. Wrongful Death Lawsuit; Announces Nationwide Investigation

McCune Law Group filed a wrongful death complaint in Alameda County Superior Court on February 2, 2026, on behalf of the family of Michael Leroy Ford, 68, of Alameda, California. According to the complaint, Ford died of cardiac arrest on November 17, 2025 after his FreeStyle Libre 3 Plus sensor displayed a reading of 68 mg/dL when his actual glucose was significantly higher. The complaint alleges Abbott knew about the manufacturing defect through internal testing but failed to disclose it until after Ford's death — by which time approximately 1.5 million defective sensors had already been used or expired. The firm announced a nationwide investigation into additional wrongful death and injury claims.

February 5, 2026

FDA Issues Class I Recall Designation & Warning Letter to Abbott

The FDA formally upgraded the FreeStyle Libre 3 sensor issue to a Class I recall — its most serious category. Separately, the FDA issued a Warning Letter to Abbott dated January 23, 2026, finding Abbott's corrective actions inadequate, its manufacturing facility's quality systems deficient, and its proposed future testing insufficient to ensure product accuracy. The agency found the devices "adulterated" and described violations as "symptomatic of serious problems" in Abbott's quality management systems.

January 2026

Individual & Class Action Lawsuits Filed in Federal Court; Injury Count Rises to 860+

Christopher Taylor and Krystal Chambers filed a personal injury complaint on January 1, 2026 in the U.S. District Court for the Northern District of California, alleging Abbott failed to promptly warn patients despite internal knowledge of the defect. Separately, plaintiff Bijoy Shroff filed a class action lawsuit seeking economic damages (refunds), not personal injury compensation. As of January 7, 2026, Abbott reported 860 serious injuries globally — up from 736 in November 2025.

November 24, 2025

Abbott Issues Medical Device Correction for ~3 Million Sensors

Abbott sent letters to affected customers recommending immediate discontinuation of impacted FreeStyle Libre 3 and Libre 3 Plus sensors. Two specific serial numbers were confirmed affected: T60003522 and T60003216. Abbott launched www.FreeStyleCheck.com for sensor verification and offered free replacements. Note: If you believe you were injured, do not dispose of your sensor — preserve it as evidence.

July 2024

Prior Class I Recall — Inaccurately High Readings

Abbott issued a voluntary Class I recall for three lot numbers of FreeStyle Libre 3 sensors providing inaccurately high glucose readings — the opposite error to the 2025 defect. Those inaccurate high readings could cause patients to administer excess insulin doses, leading to severe hypoglycemia. Lawsuits allege this prior recall should have prompted Abbott to conduct deeper quality control reviews. Injuries from the 2024 recall are also being investigated.

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