Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle L…
- Not For Use With Automated Insulin Delivery Systems Factory Calibrated Integrated Continuous Glucose Monitoring System
- Process control
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
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Model
- 78769-01
- UDI
- Code: 00357599843014 Product Expiry Date: 01/31/2026 Kit Pack
- Lot #
- T60003166 Pack
- Serial #
0HPCMWH9Y 0HPCMWHAV 0HPCMWHA9 0HPCMWHA0 0HPCMWHAK 0HPCMWHAR 0HPCMWHAU 0HPCMWHAJ 0HPCMWHAG 0J8A08TUA 0HPCMWHAQ 0HPCMWHAF 0J8A08TTZ 0J8A08TUD 0HPCMWHAT 0J8A08TTY 0J8A08TU1 0HPCMWHAZ 0J8A08TUC 0J8A08TU0…Show all
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…
Additional code information
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0JH6L …
What the firm is doing
On 11/24/2025, the firm communicated "Urgent Medical Device Correction" letter to customers and Healthcare Providers that Abbott has recently identified that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. We learned about this through our ongoing product monitoring, where Libre 3 and Libre 3 Plus sensor users reported situations where they received incorrect low glucose readings. Customers are instructed: -If you are currently wearing or have a FreeStyle Libre 3 / FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affected on www.FreeStyleCheck.com or by a customer service representative, immediately discontinue use and dispose of the affected sensor(s). You can request a replacement for any potentially affected sensor(s) on www.FreeStyleCheck.com. Select CONFIRM SENSOR SERIAL NUMBER and enter a valid serial number. If your sensor is potentially impacted, you will be instructed to enter your contact information so a replacement product can be sent to you at no cost. -Use a blood glucose meter or the built-in meter in your FreeStyle Libre 3 Reader to make treatment decisions when your sensor readings don t match your symptoms or expectations. -If you are wearing a FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensor, you can find the serial number in the app or reader. The serial number can also be found on the label on the bottom of the sensor applicator or carton. (If you are using a sensor with a connected insulin delivery device, please refer to the connected insulin delivery device user manual on how to locate the sensor serial number.) For questions/to report any adverse reactions/quality problems experienced, call Abbott Customer Service at 1-833-815-4273, available seven days a week from 8 a.m. to 8 p.m. Eastern Time. Agents are available 24/7 through live chat at https://www.freestyle.abbott/us-en/support/contact-us.html.
DistributionShow detailsHide
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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1022-2026
- FDA 510(k) clearance · K233537The device's official FDA premarket clearance record
- FDA device classification · QLGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 862.1355The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Abbott Diabetes Care, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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- Pulmonary Valve Prosthesis Percutaneously Delivered
- Process control
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination
Windstone Medical Packaging, Inc. recalls A M S
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- General Surgery Tray
- Material/Component Contamination