Recall Z-1023-2026
Abbott Diabetes Care, Inc. · initiated November 24, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Codes / lots: Model Number: 72080-01 UDI-DI Code: 00357599819002 Product Expiry Date: 01/31/2026 Kit Pack Lot Number: T60003166 Pack Serial Numbers: 0HPCMWH9Y 0HPCMWHAV 0HPCMWHA9 0HPCMWHA0 0HPCMWHAK 0HPCMWHAR 0HPCMWHAU 0HPCMWHAJ 0HPCMWHAG 0J8A08TUA 0HPCMWHAQ 0HPCMWHAF 0J8A08TTZ 0J8A08TUD 0HPCMWHAT 0J8A08TTY 0J8A08TU1 0HPCMWHAZ 0J8A08TUC 0J8A08TU0 0HPCMWHC9 0HPCMWHAX 0J8A08TUE 0J8A08TU2 0HPCMWHAM 0J8A08TUG 0HPCMWHAW 0HPCMWHAL 0J8A08TU5 0J8A08TUJ 0HPCMWHAY 0J8A08TU3 0J8A08TU8 0HPCMWHC4 0J8A08TUH 0J8A08TU7 0HPCMWHL8 0J8A08TW4 0HPCMWHLL 0HPCMWHL9 0J8A08U3T 0J8A08U45 0J8A08TW3 0J8A08U3U 0J8A08U3Q 0J8A08U3N 0J8A08TW5 0J8A08U3R 0J8A08U3C 0J8A08U3L 0J8A08TW1 0J8A08U39 0J8A08U31 0J8A08U3M 0J8A08U3A 0J8A08U2Q 0J8A08U2Z 0J8A08U3K 0J8A08U2N 0J8A08U3H 0J8A08U30 0J8A08U2P 0J8A08U36 0J8A08U43 0J8A08TV2 0J8A08U34 0J8A08U2W 0J8A08U3G 0J8A08U35 0J8A08U2K 0J8A08U2U 0J8A08U3E 0J8A08U38 0J8A08U2H 0J8A08U2L 0J8A08U2V 0J8A08U2J 0HPCMWHKW 0J8A08U2Y 0J8A08U2X 0HPCMWHL5 0HPCMWHKU 0J8A18G45 0J8A18G29 0J8A18G20 0J8A18G3W 0J8A18G3Y 0J8A18G2C 0J8A18G22 0J8A18G1Z 0J8A18G2A 0J8A18FWA 0J8A18G40 0J8A18G21 0HPD38KT2 0HPD38KTF 0HPD38KTG 0HPD38KTR 0HPD38KTH 0HPD38KTT 0HPD38KTJ 0JH6L4FC0 0JH6L4FAP 0JH6L4FC1 0JH6L4FAQ 0HPD38KRW…
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
FDA-determined cause: Process control
Action taken
On 11/24/2025, the firm communicated "Urgent Medical Device Correction" letter to customers and Healthcare Providers that Abbott has recently identified that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. We learned about this through our ongoing product monitoring, where Libre 3 and Libre 3 Plus sensor users reported situations where they received incorrect low glucose readings. Customers are instructed: -If you are currently wearing or have a FreeStyle Libre 3 / FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affected on www.FreeStyleCheck.com or by a customer service representative, immediately discontinue use and dispose of the affected sensor(s). You can request a replacement for any potentially affected sensor(s) on www.FreeStyleCheck.com. Select CONFIRM SENSOR SERIAL NUMBER and enter a valid serial number. If your sensor is potentially impacted, you will be instructed to enter your contact information so a replacement product can be sent to you at no cost. -Use a blood glucose meter or the built-in meter in your FreeStyle Libre 3 Reader to make treatment decisions when your sensor readings don t match your symptoms or expectations. -If you are wearing a FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor, you can find the serial number in the app or reader. The serial number can also be found on the label on the bottom of the sensor applicator or carton. (If you are using a sensor with a connected insulin delivery device, please refer to the connected insulin delivery device user manual on how to locate the sensor serial number.) For questions/to report any adverse reactions/quality problems experienced, call Abbott Customer Service at 1-833-815-4273, available seven days a week from 8 a.m. to 8 p.m. Eastern Time. Agents are available 24/7 through live chat at https://www.freestyle.abbott/us-en/support/contact-us.html.
Details
- Recall number
- Z-1023-2026
- Initiated
- November 24, 2025
- Posted by FDA
- January 14, 2026
- Product code
- QLG – Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
- Quantity
- 8,062 sensors
- 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, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.
- Recalling firm
- Abbott Diabetes Care, Inc., Alameda, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1020-2026 Class I | FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3…Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in… | 11/24/2025Open, Classified |
| Z-1021-2026 Class I | FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle…Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in… | 11/24/2025Open, Classified |
| Z-1022-2026 Class I | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle…Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in… | 11/24/2025Open, Classified |