FreeStyle Libre Reader batteries pose fire and swelling hazard
FreeStyle Libre Reader batteries used in glucose monitoring systems may swell, overheat, or pose a fire hazard. Users should only charge with the included cable and discontinue use if devices show damage, excessive heat, or charging problems.
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 Class I classification mandates a minimum severity of Severe (4) per the rubric. No injuries or illnesses are mentioned in the source, preventing escalation to Critical (5).
Plain-English summary
Abbott Diabetes Care, Inc. is recalling 1,534,532 FreeStyle Libre Reader devices distributed nationwide. The readers are components of the FreeStyle Libre 2 Flash Glucose Monitoring System.
Lithium-ion batteries in these readers may swell, overheat, or pose a fire hazard. The recall affects specific lot numbers across three reader models (REF 71951-01, 71952-01, and 71953-01).
Users should discontinue use of affected readers if they are damaged, cracked, swelling, too hot to hold, no longer hold charge, or fail the reader test. Only use the charging cable and power adapter included with the reader. Do not use other chargers. A user manual update provides instructions on safe storage, charging, and use.
The recalled product
- Product
- FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
- Manufacturer
- Abbott Diabetes Care, Inc.
- Hazard
- fire
- battery-swelling
- overheat
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: 71951-01/357599805005/02C313D
- 01C256D
- 03C222D
- 01C174D
- 03C166D
- 03C152D
- 01C143D
- 02C115D
- 01C084D
- 02C087D
- 01C073D
- 03B251D
- 04B251D
- 02B251D
- 02B109D
- 02B082D
- 03B082D
- 03B014D
- 04A350D
- 02A289D
Distribution
Distributed nationwide across the United States.
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