# FDA recall Z-1022-2026

> **Abbott Diabetes Care, Inc.** · Class I · device recall initiated 2025-11-24.

## 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.

## 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

## 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.

## Key facts

- **Recall number:** Z-1022-2026
- **Recalling firm:** Abbott Diabetes Care, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-24
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alameda, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1022-2026

## Citation

> AI Analytics. FDA recall Z-1022-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1022-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*