blog
By: Keith Donovan and Matthew Fogg
Key Takeaways
The FDA has identified a Class I recall (its most serious type) involving certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.
The reported issue is incorrect low glucose readings (lower than actual), which can drive dangerous treatment decisions.
Users are being told to check whether their sensor serial number is affected, stop using impacted sensors, and request replacements.
If you or a family member experienced a serious event, documentation and preservation can matter later, whether for medical care, reporting, or legal evaluation.
According to the FDA, Abbott Diabetes Care issued notifications recommending that certain glucose monitor sensors be removed from use and that patients confirm whether their sensors are impacted. The FDA has classified the action as the most serious type of recall, warning that continuing to use affected devices may cause serious injury or death.
The products identified on the FDA recall page are FreeStyle Libre 3 sensors and FreeStyle Libre 3 Plus sensors (certain lots). The FDA states that readers and mobile apps are not impacted, and that other Libre products are not impacted.
The stated reason for the recall is that some sensors may provide incorrect low glucose readings (lower than actual). If the inaccurate readings are not detected, the FDA and Abbott describe the risk as leading to wrong treatment decisions, including actions like excessive carbohydrate intake or skipping or delaying insulin doses.
On reported harms: the FDA recall page reflects Abbott’s reporting of hundreds of serious injuries and seven deaths associated with the issue (the FDA page includes an “as of” date for those figures). Abbott has separately described the scope as involving approximately 3 million sensors distributed in the U.S. and reported severe adverse events and deaths globally, noting the deaths were reported outside the U.S.
The FDA’s guidance focuses on confirming whether a sensor is affected and discontinuing impacted sensors. From a practical standpoint, we suggest users and families approach this in three tracks: safety, documentation, and preservation.
Confirm whether your sensor is affected using Abbott’s serial-number check process; the FDA points patients to Abbott’s online confirmation tool.
If confirmed as potentially affected, discontinue use and dispose of the sensor as directed.
Request a replacement through the Abbott process described on the FDA page.
If readings do not match symptoms or expectations, the FDA advises using a blood glucose meter approach for treatment decisions (and to talk with your clinician about what is appropriate for you).
If you experienced a significant incident you believe may relate to sensor readings, consider gathering:
Dates and times of the event(s).
Screenshots or exports of CGM readings and alerts (including “urgent low” alerts, if applicable).
Notes on symptoms and what actions were taken (carbohydrate intake, insulin dose held, EMS call, ER visit).
Discharge paperwork, lab results, diagnoses, and follow-up instructions.
Pharmacy records and receipts for sensors and related supplies.
In many medical-device matters, the “what exactly was used, when, and how it behaved” question becomes central. If feasible and safe:
Keep boxes, inserts, and labels that show model, lot, and serial information.
Photograph the sensor applicator/carton labels and anything showing serial numbers.
Keep a list of all sensors used during the relevant period.
Important note: The FDA guidance includes instructions on how to locate sensor serial numbers in the app/reader and on packaging.
When a widely used medical device is tied to a defined malfunction pattern (here, incorrect low readings) and the reporting suggests serious adverse outcomes, cases can move quickly from individual claims to a broader, coordinated litigation landscape.
Mass torts differ from class actions in a way that matters to families: each injured person’s medical story, causation issues, and damages are evaluated individually, even when factual issues (what happened with the device, when the manufacturer knew what, how warnings were communicated) overlap.
Every case turns on facts, but medical-device claims commonly focus on:
Product defect theories (design, manufacturing, or both).
Warnings and instructions (what users and clinicians were told, and when).
Quality systems and reporting (how complaints were tracked and escalated).
Causation (whether the specific malfunction can be connected to the outcome in the specific medical context).
Because the FDA and Abbott have described the risk in terms of treatment decisions following incorrect low readings, documentation connecting the reading, the decision, and the medical outcome is often critical.
Consider a legal consult if you have a credible reason to believe an impacted sensor may be involved and you experienced:
Hospitalization, loss of consciousness, seizure, severe hyperglycemia or hypoglycemia events, or other serious complications.
A significant disruption to diabetes management tied to sensor performance.
A fatal event in the family where device performance is a question that has not been answered.
A consult should not replace medical care. It can help you understand what information matters, what to preserve, and what timelines may apply.
Delaware Trial Lawyers Keith Donovan and Matt Fogg lead Morris James’ work in product liability and mass tort litigation, representing individuals and families in cases involving defective and dangerous products, including medical devices.
If you have questions about a potential FreeStyle Libre 3 or 3 Plus sensor claim, Morris James can help you evaluate next steps, including what records to gather and how these cases may be handled procedurally if litigation develops. Contact us at 302.655.2599 or online for a free, no-obligation consultation.
The FDA’s guidance focuses on confirming whether a sensor is affected and discontinuing impacted sensors. From a practical standpoint, we suggest users and families approach this in three tracks: safety, documentation, and preservation.
