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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Monitoring Devices

Abbott Diabetes Care, Inc.: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Agency Publication Date: January 14, 2026
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Summary

Abbott Diabetes Care, Inc. is recalling over 1 million FreeStyle Libre 3 Sensors (Model REF 72081-01) because a manufacturing issue may cause carbon build-up in the device. This defect can lead the sensor to display glucose readings that are incorrectly low. Users should check their kit lot numbers and pack serial numbers against the affected list to determine if their sensor is part of this critical recall.

Risk

Incorrectly low glucose results can lead to a 'missed' hyperglycemia (high blood sugar) diagnosis or unnecessary treatments that could cause dangerous hypoglycemia. This poses a critical risk to patients who rely on the device for life-sustaining insulin dosing decisions.

What You Should Do

  1. Immediately check your FreeStyle Libre 3 sensor packaging for Model Number 72081-01 and UDI-DI 00357599818005.
  2. Verify if your device is affected by matching the Kit Lot Number (T60003054) or the specific Pack Serial Number against the extensive list provided in the recall notice.
  3. If your sensor is confirmed to be part of the affected lot, stop using that specific sensor immediately and switch to a different, unaffected sensor or use a blood glucose meter.
  4. Contact Abbott Diabetes Care, Inc. directly to report the affected unit and receive instructions on how to obtain a replacement.
  5. Visit the manufacturer's website or contact the FDA Device surveillance team for further guidance on verifying your specific serial number if you are unsure.

Affected Products

Product: FreeStyle Libre 3 Sensor (Component of FreeStyle Libre 3 Continuous Glucose Monitoring System)
Model / REF:
72081-01
UDI-DI 00357599818005
Lot Numbers (226):
T60003054
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
Date Ranges: Expiry Date 12/31/2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98049
Status: Active
Manufacturer: Abbott Diabetes Care, Inc.
Manufactured In: United States
Units Affected: 4 products (1,060,723 sensors; 1,663,241 sensors; 258,913 sensors; 8,062 sensors)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.