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The Food and Drug Administration (FDA) issued a strong warning on Tuesday of malfunctioning anti-inflammatory drugs that have contributed to seven deaths and hundreds of serious injuries.
Medical Equipment Manufacturer Abbott also notified health users and distributors last Monday, urging them to stop using or discard all Freestyle 3 Sensor Plle devices.
The FDA described the problem as a “high-risk” problem.
“As of November 14, 2025, Abbott has reported seven serious injuries and deaths related to this issue,” the FDA said. Abbott noted that 57 of the negative negative events “occurred in the US, and none of the deaths occurred in the country.
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A young diabetic is fitted with a glucose sensor. (BSIP / Global Images / Global Images)
Both the FDA and Abbott warned that the monitors could “provide false glucose readings” and warned patients to check if their nerves are affected.
“Abbott has begun processing the Freestyle Exericre 3 and Freeteryle Free 3 medical devices and sensors in the US after an internal review,” Abbott told Fox Business on Tuesday.
“If undetectable, inaccurate readings of glucose in the long term can lead to inappropriate management decisions, they can lead to people living with diabetes, such as consuming too much carbohydrate or skipping insulin doses,” said FDA and Abbott. “These decisions can pose serious health risks, including injury or death, as well as other serious problems.”
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A four-year-old child shows a glucose sensor on his arm as he measures his blood sugar in Berlin, Germany, on Aug. 3, 2021. (Jörg Carstensen / Photo Alliance / Final Images)
The sensors involved are real-time monitoring devices with alarm capabilities, designed to help manage blood sugar in people aged four and over.
Abbott said the company has identified and resolved a manufacturing issue related to these devices, noting that the issue affects only one production line other than the components used to make the sensors. About three million sensors from the affected line were affected, the company said.
The manufacturer said it will produce new devices to fulfill the replacement and new orders and that the company does not expect significant disruptions.
| It’s teasing | Security | – Last | Answer | Change % |
|---|---|---|---|---|
| Abisa | Laboratories | 126.32 | -1.75 |
-1.37% |
Consumers can visit www.freestyleckech.com to find out if their sensors are affected and find a replacement at no charge, Abbott added.
Abbott Labories Signage seen at its campus headquarters in Abbott Park, Illinois, on Friday, May 21, 2010. (Tim Boyle/Bloomberg/Getty Images)
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The company stressed that no other libre family sensors, readers or applications were affected.
FOX News Digital has reached out to the FDA for more information.
