FDA Medical devices recall · January 21, 2026

FreeStyle Libre 3 Plus Sensor recall

This is an FDA Class I recall — the most serious type.

Read the official FDA notice ↗

Product

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.

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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 0J8A08U2J 0HPCMWHKW 0J8A08U2Y 0J8A08U2X 0HPCMWHL5 0HPCMWHKU 0J8A18G45 0J8A18G29 0J8A18G20 0J8A18G3W 0J8A18G3Y 0J8A18G2C 0J8A18G22 0J8A18G1Z 0J8A18G2A 0J8A18FWA 0J8A18G40 0J8A18G21 0HPD38KT2 0HPD38KTF 0HPD38KTG 0HPD38KTR 0HPD38KTH 0HPD38KTT 0HPD38KTJ 0JH6L4FC0 0JH6L4FAP 0JH6L4FC1 0JH6L4FAQ 0HPD38KRW 0JH6L4FAR 0HPD38KT8 0HPD38KT7 0HPD38KTL 0HPD38KTK 0HPD38KTM 0HPD38KTA 0HPD38KTN 0HPD38KTC 0HPD38KTP 0HPD38KTD 0JH6L4FAV 0JH6L4FC6 0JH6L4FAW 0JH6L4FC2 0JH6L4FAX 0JH6L4FC3 0HPD38KR5 0J8A18G1R 0J8A18G1K 0HPD38KRK 0J8A18G1T 0J8A18G1V 0J8A18G1H 0J8A18G1L 0J8A18G1W 0J8A18G82 0J8A18G8R 0J8A18G1J 0J8A18G1U 0J8A1

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: Alaska Alabama Arizona California Colorado Florida Georgia Iowa Idaho Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Jersey Nevada New York Ohio Oklahoma Pennsylvania South Carolina South Dakota Texas Utah Virginia Wisconsin West Virginia Wyoming

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-1022-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.