FDA Device recall Z-1021-2026
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li…
- FDA Device
- Class I
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class I recall of FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li… by Abbott Diabetes Care, citing due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1021-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-11-24 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Abbott Diabetes Care |
| Distribution | 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, WY |
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
Identifiers
| code_info | Model Number: 78768-01 UDI-DI Code:00357599844011 Product Expiry Date: 12/31/2025 Kit Pack Lot Number: T60003138 Pack S…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 0HKCMA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1021-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.