Severe FDA (Devices)·Z-1273-2023·Announced 2023-04-12

FreeStyle Libre Readers recalled due to lithium-ion battery fire hazard

FreeStyle Libre Reader batteries may swell, overheat, or create fire hazard. Do not use if the device is damaged, cracked, swollen, excessively hot, won't hold charge, or fails Reader Test.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classified this as Class I, which mandates a minimum severity score of 4. The hazard involves potential fire or thermal damage from lithium-ion battery defects in a widely distributed medical device. No illnesses or injuries have been reported to date.

Plain-English summary

Abbott Diabetes Care, Inc. is recalling FreeStyle Libre Readers (models REF 71525-01, 71701-01, and 71739-01), which are components of the FreeStyle Libre Flash Glucose Monitoring System. Approximately 336,085 units were distributed nationwide.

The lithium-ion batteries in these readers may swell, overheat, or pose a fire hazard. Only the charging cable and power adapter included with the reader should be used; other chargers are unsafe.

Patients using affected devices should discontinue use immediately if the reader is damaged, cracked, swelling, too hot to hold, will no longer hold a charge, or fails the Reader Test. Consult the updated User Manual for instructions on safe storage and proper charging.

The recalled product

Product: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
Manufacturer: Abbott Diabetes Care, Inc.
Category: Medical Device — Glucose Monitoring Device
Hazard: fire
battery-swell
thermal-hazard
Affected units: 336,085

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

REF/UDI-DI/Lot: 71525-01/357599000219/02Y702D
01Y699D
02Y699D
01Y698D
02Y697D
04Y690D
03Y690D
01Y683D
02Y683D
01Y674D
02Y672D
01Y669D
02Y666D
01Y659D
02Y658D
02Y656D
04Y655D
01Y655D
01Y652D
02Y653D

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Abbott Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Abbott Diabetes Care, Inc.

See all →

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FreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings
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Same hazard · fire