Abbott FreeStyle Libre 3 Sensor Recall - Incorrect Glucose Results

FDA: Device Recalls Class I

Filed January 21st, 2026

Detected March 27th, 2026

Summary

The FDA has issued a Class I recall for Abbott's FreeStyle Libre 3 Plus Sensor due to a manufacturing defect that may cause incorrect low glucose results. This recall impacts devices distributed across multiple U.S. states and requires immediate attention from healthcare providers and potentially patients.

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What changed

The FDA has classified a recall of Abbott's FreeStyle Libre 3 Plus Sensor (REF 78769-01) as Class I, indicating a serious health risk. The recall stems from a manufacturing process issue that can lead to carbon buildup in the sensor, potentially causing inaccurate low glucose readings. This defect poses a significant risk to patient safety, as incorrect glucose measurements can lead to improper treatment decisions.

Healthcare providers and potentially patients who have received or are using the affected FreeStyle Libre 3 Plus Sensors should be aware of this recall. While the document does not specify immediate actions for patients, healthcare providers should review their inventory and patient communications regarding this product. The recall is ongoing, and further information regarding specific remediation steps or patient notification may be forthcoming from Abbott or the FDA.

What to do next

Review inventory of FreeStyle Libre 3 Plus Sensors (REF 78769-01) for potential recall.
Communicate with patients who may have received affected devices.
Monitor Abbott's communications regarding specific remediation steps.

Source document (simplified)

Abbott Diabetes Care, Inc.

Device Recalls (Class I)

← All Device Recalls (Class I) Class I Z-1022-2026 · 20260121 · Ongoing

Product

FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Reason for Recall

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Distribution

U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, a...

Source: openFDA Enforcement API