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FreeStyle Libre 71701Recalls & reported problems

Abbott Diabetes Care Inc · FreeStyle Libre Reader Kit US · Class 3

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 13, 2023Open, Classified

    Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.

    Z-1273-2023 · Root cause: Device Design · FDA record ↗

Other Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated devices

All Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated devices →

Sources and updates

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