Recall archive / FDA device enforcement
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System — FDA record Z-2692-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 24, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
- Reason
- Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.
- Classification
- Class I
- Recalling firm
- Abbott Diabetes Care, Inc.
- Quantity
- 8,174
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2692-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00357599818005. Lot/Serial Numbers: T60001948/0FP5Z6330 0FP5Z633C 0FP5Z90AF 0FP5Z90AL 0FP5Z90AR 0FP5Z90AX 0FP5Z90AZ 0FP5Z90C0 0FP5Z90C1 0FP5Z90C2 0FP5Z90C3 0FP5Z90C4 0FP5Z90C5 0FP5Z90C6 0FP5Z90C7 0FP5Z90C8 0FP5Z90CA 0FP5Z90CC 0FP5Z90CD 0FP5Z90CE 0FP5Z90CF 0FP5Z90J1 0FP5Z90J2 0FP5Z90J3 0FP5Z90J4 0FP5Z90J5 0FP5Z90J6 0FP5Z90J7 0FP5Z90J8 0FP5Z90J9 0FP5Z90JA 0FP5Z90JC 0FP5Z90JE 0FP5Z90JF 0FP5Z90JG 0FP5Z90JH 0FP5Z90JJ 0FP5Z90JK 0FP5Z90JM 0FP5Z90JN 0FP5Z90JR 0FP5Z90JT 0FP5Z90JU 0FP5Z90JX 0FP5Z90K0 0FP5Z90K2 0FP5Z90K3 0FP5Z90K4 0FP5Z90K5 0FP5Z90K6 0FP5Z90K7 0FP5Z90K8 0FP5Z90K9 0FP5Z90KC 0FP5Z90KD 0FP5Z90KE 0FP5Z90KF 0FP5Z90KG 0FP5Z90KH 0FP5Z90KJ 0FP5Z90KL 0FP5Z90KM 0FP5Z90KP 0FP5Z90KQ 0FP5Z90KR 0FP5Z90KT 0FP5Z90KU 0FP5Z90KV 0FP5Z90KW 0FP5Z90KY 0FP5Z90KZ 0FP5Z90L0 0FP5Z90L2 0FP5Z90L4 0FP5Z90L5 0FP5Z90L6 0FP5Z90L7 0FP5Z90L9 0FP5Z90LA 0FP5Z90LC 0FP5Z90LD 0FP5Z90T2 0FP5Z90T4 0FP5Z90T6 0FP5Z90T8 0FP5Z90T9 0FP5Z90TA 0FP5Z90TC 0FP5Z90TD 0FP5Z90TE 0FP5Z90TF 0FP5Z90TG 0FP5Z90TH 0FP5Z90TK 0FP5Z90TL 0FP5Z90TP 0FP5Z90TQ 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Distribution
US distribution to states of: NJ, PA, OH, TX, VA, CA, NY, FL, WA, MS, MN, and WY
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 4, 2024
- Recall initiation date
- Jul 24, 2024
- Center classification date
- Aug 27, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.