Recall archive / FDA device enforcement

FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a compone... — FDA record Z-1021-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Recalling firm: Abbott Diabetes Care, Inc.
Quantity: 1,663,241 sensors
Agency-reported status: Ongoing
Source record identifier: Z-1021-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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 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0HU6HAVUR 0HU6HAVUY 0HU...

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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 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0HWDCHF1H 0HWDCHF14 0HWDCHF1J 0HWDCHF1F 0HWD9FV9U 0HWD9FV9J 0HWD9FV9W 0HWD9FV9H 0HWD9FV9T 0HWD9FV9V 0HWDCHF12 0HWDCHF0Q 0HWD9FV9R 0HWD9FV9G 0HWDCHF10 0HWDCHF0N 0HWDCHF0R 0HWDCHF11 0HWDCHF0Y 0HWD9FVA9 0HWDCHF0P 0HWDCHF0Z 0HWD9FVA0 0HWD9FV9Y 0HWDCHF0M 0HWD9FV9Z 0HWDCHF0X 0HWDCHF0K 0HWD9FV9X 0HWD9FV9M 0HWDCHF0V 0HWDCHF0H 0HWDCHF0L 0HWDCHF0W 0HWDCHF0T 0HWD9FVAF 0HWDCHF0J 0HWDCHF0U 0J8A18QTU 0J8A18QU7 0J8A18QTV 0J8A18QU8 0J8A18QTW 0J8A18QU9 0J8A18QTX 0J8A18QTF 0J8A18QT4 0J8A18QT5 0J8A18QTH 0J8A18QT6 0HPCNHP3Y 0HPCNHP3L 0HPCNHP3P 0HPCNHP3Z 0HKCMANCD 0HKCMANCP 0HPCNHP3M 0HKCMANCC 0HKCMANC9 0HKCMANCL 0HKCMANC8 0HKCMANCU 0HKCMAND4 0HKCMANCK 0HKCMANCA 0HKCMANCW 0HKCMAND6 0HKCMANCM 0HKCMANCV 0HKCMAND9 0HKCMAND5 0HKCMANCX 0HKCMANCF 0HKCMANCZ 0HKCMANCQ 0HKCMAND1 0HKCMANMC 0HKCMANCT 0HKCMAND3 0HKCMANM9 0HKCMANDC 0HKCMAND2 0HPCNHNJ6 0HPCNHNKF 0HPCNHNK4 0HKCMAN3H 0HPCNHNKD 0HPCNHNK2 0HKCMAN36 0HPCNHNKE 0HPCNHNKA 0HPCNHNK0 0HPCNHNK3 0HPCNHNKC 0HKCMAN2Z 0HKCMAN2N 0HPCNHNK1 0HKCMAN30 0HKCMAN32 0HKCMAN2R 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0HU...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jan 21, 2026
Recall initiation date: Nov 24, 2025
Center classification date: Jan 13, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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