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Use caution Medical device recall · FDA · Published February 9, 2023

FreeStyle Libre 3 App on Android 13: Signal Loss Risk

Abbott recalls FreeStyle Libre 3 app for Android 13 OS versions 3.4.0 and below due to potential signal loss causing undetected glucose levels. Users may need to update or switch OS.

🇺🇸 FDA recall #Z-0734-2024Medical deviceAbbott Diabetes Care ›
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Contact the company

Recalling firmAbbott Diabetes Care, Inc.1360 S Loop Rd · Alameda, CA 94502-7000
✎ GovInfoNow plain-language explainer

Abbott is recalling the FreeStyle Libre 3 app for Android 13 OS versions 3.4.0 and below because signal loss can cause missed glucose readings. This could lead to dangerous high or low blood sugar levels if not treated properly. Read more at govinfonow.com/recall/58919-freestyle-libre-3-app-on-android-13-signal-loss-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58919-freestyle-libre-3-app-on-android-13-signal-loss-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0734-2024

Cite this page

“FreeStyle Libre 3 App on Android 13: Signal Loss Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58919-freestyle-libre-3-app-on-android-13-signal-loss-risk. Based on FDA recall #Z-0734-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0734-2024%22&limit=1).

The FDA announced on Feb. 9, 2023, that Abbott Diabetes Care is recalling the FreeStyle Libre 3 App for use on Android 13 due to signal loss risks. The recall affects approximately 45,173 units distributed nationwide.

How to tell if you have it

  • FreeStyle Libre 3 App
  • Continuous Glucose Monitoring System
  • Android 13 Operating System
  • UDI-DI: 00357599816001
  • Software v.3.4.0 and below

The hazard

Extended periods of signal loss may occur because the app is not connected, potentially impacting the ability to receive glucose readings or alarms. This could lead to undetected low or high glucose levels and result in delayed treatment, such as failing to take insulin for high glucose or glucose for low glucose.

Context

GovInfoNow's records show Abbott Diabetes Care has five other recalls on record since Nov. 14, 2019. Other recent recalls of similar products include FreeStyle Libre 3 Plus Sensor Recall (Nov. 24, 2025), Abbott FreeStyle Libre 3 Sensors (July 24, 2024), and FreeStyle Libre 2 Readers (July 12, 2023). Other recent recalls of similar products include Tandem t:slim App Recall (July 16, 2026) and Dexcom G7 CGM App recalls (April 14, 2026).

How to tell if you have this one

Check if you have the FreeStyle Libre 3 app installed on Android 13 OS versions 3.4.0 and below. The unique identifier (UDI-DI) is 00357599816001.

  • Brand
    Abbott Diabetes Care
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Update the App

    Update the FreeStyle Libre 3 app to version 3.4.1 or later for Android 13 OS.

  2. Check Device Compatibility

    Ensure your device runs Android 13 OS with the updated app version to avoid signal loss.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 19 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of NY, CA, NJ, UT, PA, MS, OH, TX, MN, FL, LA, NE, MI, VA, NC, MA, IN, SC, IA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Indiana, Iowa, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia.

Recall timeline

FDA published this recall 11 months after the firm started it.

1. Firm started the recall: Feb 9, 202312. FDA classified it Class II: Jan 16, 202423. Published in FDA’s Enforcement Report: Jan 24, 2024320232024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0734-2024 (February 9, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0734-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA