Abbott Diabetes Care, Inc. medical device recall: FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The…

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

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Nov 24, 2025. FDA classified it 50 days later, on Jan 13, 2026. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: 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. Abbott Diabetes Care, Inc. has 9 recalls in our records.

Recalled products (4)

• Z-1020-2026 Class I Ongoing

  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…

  Quantity: 1,060,723 sensors

• Z-1021-2026 Class I Ongoing

  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.

  Codes / lots: 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…

  Quantity: 1,663,241 sensors

• Z-1022-2026 Class I Ongoing

  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.

  Codes / lots: Model Number: 78769-01 UDI-DI Code: 00357599843014 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…

  Quantity: 258,913 sensors

• Z-1023-2026 Class I Ongoing

  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…

  Quantity: 8,062 sensors