The decision to recall approximately three million sensors follows reports of potentially life-threatening errors in the devices. The malfunction causes the sensors to deliver incorrect low glucose readings, which could lead patients to make dangerous decisions regarding their insulin doses and carbohydrate intake. The issue has already been linked to hundreds of serious injuries and even fatalities.
Safety Risks Linked to Faulty Sensors
Abbott’s recall of FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors stems from concerns that these devices may give inaccurate low glucose readings. According to the US Food and Drug Administration (FDA), if these incorrect readings go unnoticed, they could result in patients either over-consuming carbohydrates or skipping necessary insulin doses—both of which could lead to severe complications such as hypoglycemia or hyperglycemia.
As of mid-November 2025, over 700 serious injuries and seven deaths have been reported in connection with the malfunction. The FDA acknowledged that the affected sensors, those with specific model numbers and unique device identifiers (UDI), could compromise the safety of diabetes management, especially if patients rely solely on the readings for treatment decisions.
Abbott has assured customers that the recall does not affect the FreeStyle Libre 3 readers or mobile apps, nor does it extend to other Libre products like FreeStyle Libre 2 or Libre Pro sensors. The company has set up a website, FreeStyleCheck.com, for users to verify if their sensors are impacted and to request free replacements if necessary.
How Patients and Providers Are Affected
The recall is not just an inconvenience for patients but raises critical concerns for healthcare providers as well. Since many diabetes patients rely on continuous glucose monitoring systems like the FreeStyle Libre 3, the recall has created significant challenges for both patients and healthcare professionals in ensuring proper management of the condition.
For patients who may be using an affected sensor, Abbott recommends immediate discontinuation of the device. The company urges users to dispose of their sensors and consult their glucose meter or FreeStyle Libre reader to make treatment decisions in the meantime. In addition, patients can easily confirm whether their devices are part of the recall by visiting the official website and entering their sensor’s serial number.
Healthcare providers have been asked to inform their patients about the recall and direct them to the website for guidance. Abbott also provides a letter for doctors to use in notifying affected patients.
This recall extends beyond the US and UK, affecting multiple countries worldwide. Abbott has already contacted distributors, urging them to return affected devices, and is working to ensure replacement sensors are available as quickly as possible.
While Abbott works to address the problem, the recall serves as a reminder of the inherent risks of medical technology, especially when it involves devices integral to managing serious health conditions. The company’s swift response aims to mitigate the risks posed by these faulty glucose monitors, but the broader question of ensuring product safety across global markets remains a key concern.
