Abbott FreeStyle Libre 3 Recall Over Faulty Glucose Sensor Readings Linked to Multiple Deaths

Manufacturer is advising customers to stop using the devices immediately and resort to other means of monitoring glucose levels.

Abbott is warning that more than 3 million FreeStyle Libre 3 and Libre 3 Plus sensors may provide inaccurate readings, which could lead to unnecessary insulin dosing, fainting episodes, emergency room visits and potentially fatal complications.

The Abbott FreeStyle Libre 3 recall was announced in a press release on November 24, following more than 700 reports of serious health consequences linked to devices producing falsely low results.

Glucose sensors are small devices worn on the upper arm that continuously track blood sugar levels, a critical tool for people with diabetes who rely on real-time data to avoid dangerous highs and lows. By showing current levels and trends, the sensors help users adjust medication, food intake and daily activity.

However, the manufacturer reports that internal testing of certain FreeStyle Libre 3 units found that some may generate undetected false lows for extended periods. This can mislead users into taking insulin they do not need, increasing the risk of severe hypoglycemia, confusion, loss of consciousness and other life-threatening complications.

Abbott reported in its medical device correction notice that it received at least 736 severe adverse events reports globally, with 57 occurring in the U.S. Seven deaths potentially linked to the issue are also being investigated.

The current recall impacts approximately 3 million Abbott FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S., about half of which are estimated to have already expired or been used. 

Consumers are being instructed to visit www.FreeStyleCheck.com to determine whether their sensor is affected and to request a replacement. Libre 3 readers and mobile apps are not impacted by this action. 

If consumers are currently wearing or have an affected sensor, Abbott advises them to stop using it immediately and dispose of it properly. The company reports that the underlying issue has been identified and resolved, and it is continuing to manufacture Libre 3 and Libre 3 Plus sensors for replacements and new orders. 

Consumers are advised to use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to guide treatment decisions when sensor readings do not match symptoms or expectations.

For more information, customers can visit www.FreeStyleCheck.com or call Abbott customer service at 1-833-815-4273, which is available seven days a week from 8 a.m. to 8 p.m. ET.

Glucose Monitor Safety Risks

Recent reports have also raised broader concerns about the safety and reliability of certain diabetes management devices.

In August, Tandem Diabetes Care recalled certain insulin pumps after receiving more than 700 reports of severe hyperglycemia or other medical interventions, along with nearly 60 injuries. The incidents were traced to a speaker malfunction that triggered an error message and halted insulin delivery.

Dexcom also announced a recall related to its continuous glucose monitors (CGMs) earlier this year. These devices were recalled after more than 50 reported injuries were tied to devices failing to sound alerts for dangerously high or low blood sugar levels.

Earlier this month, a Tennessee woman filed a wrongful death lawsuit against Dexcom, alleging that the company’s continuous glucose monitor failed to alert her husband to a dangerous spike in blood sugar. The complaint states that while he had effectively managed his diabetes for more than 25 years with other devices, the undetected hyperglycemia caused by the monitor’s failure ultimately led to his death.

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