Recall Z-1020-2026
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 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Codes / lots: Model Number: 72081-01 UDI-DI Code: 00357599818005 Product with Expiry Date 12/31/2025 Kit Lot Numbers: T60003054 Pack Serial Numbers: 0HYCDDYCC 0HYCDDYC1 0HYCDDY3A 0HYCDDYCE 0HYCDDY32 0HYCDDY3D 0HYCDDYC2 0HYCDDY34 0HYCDDY3F 0JAET01AW 0HYCDDY33 0HYCDDY3H 0HYCDDY3E 0HYCDDY35 0HYCDDYKL 0HYCDDYKK 0JAET02A8 0JAET029Z 0HYCDDYK9 0JAET02A7 0JAET02AA 0JAET029Y 0JAET02A9 0HYCDDYKP 0JAET02A0 0HYCDDYKN 0HYCDDYKR 0JAET02A2 0HYCDDYKD 0HYCDDYKQ 0JAET02AE 0JAET02A4 0HYCDDYKF 0JAET02AD 0JAET02AG 0JAET02A6 0JAET02A3 0JAET02AF 0HYCDDY2N 0HYCDDY2C 0JAET02A5 0HYCDDY2M 0JAET01AZ 0JAET01AV 0HYCDDY2A 0HYCDDY2P 0JAET01AX 0JAET01L3 0JAET01AU 0JAET01C0 0JAET01K3 0JAET01JT 0JAET01C1 0HYCDDY2U 0HYCDDY2H 0JAET01L2 0HYCDDY2T 0JAET01L1 0JAET01KU 0HYCDDY2G 0JAET019H 0JAET01KT 0JAET01KY 0JAET01KV 0JAET01L0 0JAET01JY 0JAET01KZ 0JAET01KR 0HYCDDZKC 0HYCDDZKN 0JAET039T 0HYCDDZKA 0HYCDDZKE 0HYCDDZKQ 0HYCDDZKM 0HYCDDZKD 0JAET03AL 0JAET03AX 0HYCDDZKP 0JAET0E3M 0JAET0E3A 0JAET0E3L 0JAET0E39 0JAET0E96 0JAET0E97 0JAET0E9J 0JAET0E98 0JAET0E9K 0JAET0E99 0JAET0E9L 0JAET0E9A 0JAET0E9M 0JAET0A33 0JAET0A2M 0JAET0EA2 0JAET0EAD 0JAET0EA3 0JAET0EAE 0JAET0E9C 0JAET0E9N 0JAET0E9D 0JAET0E9P 0JAET0E9E 0JAET0E9Q 0JAET0E9F 0JAET0E9R…
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-1020-2026
- 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
- 1,060,723 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-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 |
| Z-1023-2026 Class I | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 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 |