Agency classClass IOur severity:Severe FDA (Devices)·Z-1275-2023·Announced 2023-04-12

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category: Medical Device — Glucose Monitoring System
Hazard: fire
battery-swelling
overheat
Affected units: 1,534,532

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.

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 →

Critical
Libre 3 Plus sensors, REF 78769-01, recalled over carbon build up
FDA (Devices) · 2026-01-21
Critical
Libre 3 Plus sensors recalled in a second lot over carbon build up
FDA (Devices) · 2026-01-21
Critical
Glucose monitoring sensors recalled over carbon build up causing low readings
FDA (Devices) · 2026-01-21
Critical
Libre 3 Plus sensors recalled over carbon build up causing low readings
FDA (Devices) · 2026-01-21
Severe
FreeStyle Libre 3 Sensors Recalled for Inaccurate Glucose Readings
FDA (Devices) · 2024-09-04

Same hazard · fire