Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Plus Sensor REF 78768-01

Recalling company

Abbott Diabetes Care, Inc.

Product

FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

Reason

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

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Nov 24, 2025

Reported

Jan 21, 2026

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.

Status

Ongoing

Quantity

1,663,241 sensors

Lot / codes

Model Number: 78768-01 UDI-DI Code:00357599844011 Product Expiry Date: 12/31/2025 Kit Pack Lot Number: T60003138 Pack Serial Numbers: 0HWDCHEU5 0HWD9FV3H 0HWD9FV36 0HWDCHEUG 0HWD9FV3J 0HWD9FV34 0HWD9FV37 0HWD9FV3G 0HWD9FUVX 0HWD9FV40 0HWD9FV35 0HWD9FV3K 0HWD9FUVZ 0HWD9FV3Y 0HWD9FV38 0HWD9FUVY 0HWD9FV3W 0HWD9FV32 0HWD9FV3Z 0HWD9FUW0 0HWD9FV2Q 0HWD9FV30 0HWD9FUW1 0HWD9FV2R 0HWD9FUW2 0HWD9FV3V 0HWD9FV31 0HWD9FV3E 0HWD9FV43 0HWD9FV33 0HWD9FUW3 0HWDCHEAD 0HWDCHEAQ 0HWDCHEAE 0HWD9FULN 0HWD9FULP 0HWD9FULM 0HWD9FULC 0HWD9FULL 0HWD9FULA 0HWDCHEAR 0HWD9FULK 0HWDCHEAT 0HWDCHEAG 0HWDCHEAU 0HWDCHEAH 0HWDCHEAV 0HWDCHEAJ 0HWDCHEAW 0HWDCHEAK 0HWD9FULH 0HWD9FULJ 0HWD9FULG 0HWD9FULD 0HWD9FULF 0HWD9FUL5 0HWD9FUL8 0HWD9FULE 0HWD9FUKR 0HWD9FUL2 0HWD9FUKQ 0HWD9FUL1 0HWD9FUKP 0HWD9FUL0 0HWD9FUKN 0HWD9FUKZ 0HWD9FUKM 0HWD9FUKY 0HWDCHEC9 0HWDCHEAX 0HWDCHECA 0HWDCHEAY 0HWD9FUL3 0HWDCHEAZ 0HWD9FUKL 0HWD9FUKX 0HWD9FUKK 0HWD9FUKW 0HWD9FUKV 0HKCMAM2P 0HKCMAM2E 0HKCMAM2N 0HKCMAM2D 0HKCMAM2M 0HKCMAM2C 0HPCNHMJT 0HKCMAM2A 0HPCNHMJX 0HPCNHMJG 0HPCNHMJW 0HPCNHN24 0HPCNHN1T 0HPCNHN23 0HPCNHN1R 0HPCNHN22 0HPCNHN1Q 0HPCNHN21 0HKCMAMK8 0HKCMAMKK 0HKCMAMK7 0HKCMAMKJ 0HKCMAMK6 0HKCMAMKH 0HKCMAM02 0HKCMAMKG 0HKCMAM01 0HKCMAM81 0HKCMAM0A 0HKCMAM82 0HKCMAM09 0HKCMAM8K 0HKCMAM88 0HKCMAM8L 0HKCMAM8M 0HKCMAM8A 0HKCMAM8N 0HKCMAM8C 0HKCMAM84 0HKCMAM8D 0HKCMAM85 0HKCMAM06 0HKCMAM86 0HKCMAM05 0HKCMAM87 0HKCMAM04 0HKCMAM8Q 0HKCMAM8E 0HKCMAM8R 0HKCMAM8T 0HKCMAM8G 0HKCMAM8U 0HKCMAM8H 0HKCMAM8P 0HKCMAM8J 0HPCNHMU7 0HPCNHMTX 0HPCNH

Company location

Alameda, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-1021-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1021-2026 in the FDA Enforcement Report. Also see FDA recall press releases.