FreeStyle Libre 3 Plus Sensor Recall: Potential Incorrect Low Glucose Readings
Abbott is recalling approximately 258,913 FreeStyle Libre 3 Plus Sensors due to carbon buildup that may cause incorrect low glucose readings. The affected sensors expire on 01/31/2026.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall. Although no illnesses or deaths have been reported, the manufacturing defect may result in incorrect glucose readings in a critical medical device used for diabetes management, which cannot go below a score of 4 per the Class I designation.
Plain-English summary
Abbott Diabetes Care is recalling approximately 258,913 units of the FreeStyle Libre 3 Plus Sensor (Model 78769-01, UDI-DI 00357599843014).
A manufacturing process issue may cause carbon buildup in the sensor that could result in incorrect low glucose readings. The sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
The affected sensors expire on 01/31/2026 and were distributed across the United States (all 50 states and territories) and internationally to Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.
The recalled product
- 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.
- Manufacturer
- Abbott Diabetes Care, Inc.
- Hazard
- carbon-buildup
- inaccurate-glucose-reading
Distribution
Distributed in 36 states:
- 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
- WY
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27