FreeStyle Libre Readers Recalled for Battery Swelling and Fire Hazard
Abbott is recalling over 1.3 million FreeStyle Libre Readers nationwide due to lithium-ion battery swelling, overheating, and fire hazards. Users should stop use if devices show damage, swelling, or excessive heat.
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: This is an FDA Class I recall, which establishes a minimum severity of 4 per the classification rule. The source reports no deaths, injuries, or confirmed illnesses, preventing classification as Critical (5). The lithium-ion battery hazards (swelling, overheating, fire risk) represent serious potential harm.
Plain-English summary
Abbott Diabetes Care, Inc., is recalling the FreeStyle Libre Reader, a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System. The recall affects over 1.3 million units distributed nationwide in the United States.
The lithium-ion batteries in these readers may swell, overheat, or pose a fire hazard. Users may also experience issues where the device will no longer hold a charge or fails the Reader Self-Test.
Consumers should stop using the reader if it is damaged, cracked, swelling, too hot to hold, will no longer hold a charge, or fails the Reader Test. Users must only use the charging cable and power adapter provided with the reader and must not use other chargers. The updated User Manual contains new instructions for safe storage, charging, and use of the reader.
The recalled product
- Product
- FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
- Manufacturer
- Abbott Diabetes Care, Inc.
- Hazard
- battery-swelling
- battery-fire
- overheating
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: 71936-01/357599000981/01C083D
- 02C054D
- 03C033D
- 03B356D
- 01B320D
- 03B266D
- 02B250D
- 02B181D
- 01B161D
- 01B096D
- 05B081D
- 03B035D
- 02A314D
- 02A238D
- 02A191D
- 01A160D
- 03A132D
- 01A093D
- 02A085D
- 01A074D
Distribution
Distributed nationwide across the United States.
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