FDA Device recall Z-2414-2023

FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

FDA Device
Class II
ongoing
Published 2023-08-23

On 2023-08-23 the FDA classified a Class II recall of FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System by Abbott Diabetes Care, citing if blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Se….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2414-2023
Classification	Class II
Status	ongoing
Initiated	2023-07-12
Published	2023-08-23
Last updated	2026-09-13 11:56 UTC
Company	Abbott Diabetes Care
Distribution	US

Product

FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System

Reason

If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

Identifiers

code_info	REF/UDI-DI/Lots: 71951-01/357599805005/02A289D, 03B082D, 02B082D, 02B109D, 03B251D, 04B251D, 01C073D, 01C084D, 02C087D,… REF/UDI-DI/Lots: 71951-01/357599805005/02A289D, 03B082D, 02B082D, 02B109D, 03B251D, 04B251D, 01C073D, 01C084D, 02C087D, 01C143D, 03C152D, 03C166D, 01C174D, 03C222D, 01C256D, 02C313D, 01D018D, 02D093D, 02D129D; 71953-01/357599803001/01A198D, 02A198D, 03A198D, 04A198D, 05A198D, 01A202D, 04A202D, 01A204D, 02A203D, 02A205D, 03A205D, 01A211D, 02A211D, 03A210D, 02A212D, 04A218D, 05A218D, 06A218D, 01A219D, 04A225D, 05A225D, 01A231D, 03A231D, 02A232D, 06A232D, 02A240D, 02A248D, 01A259D, 01A260D, 04A262D, 03A266D, 01A267D, 02A268D, 03A268D, 02A280D, 01A281D, 01A283D, 02A283D, 01A290D, 02A297D, 02A298D, 03A296D, 02A303D, 02A304D, 04A325D, 01A328D, 03A325D, 02A340D, 03A344D, 02A351D, 03A350D, 01A352D, 03A352D, 02A358D, 01A364D, 02A363D, 01B007F, 02B007F, 01B008F, 01B011F, 03B012F, 01B012F, 01B014F, 05B013F, 01B015F, 04B013F, 02B013F, 11B021F, 02B034F, 02B035F, 04B034F, 04B035F, 06B034F, 07B034F, 02B036F, 05B035F, 01B036F, 01B039F, 03B039F, 03B036F, 03B041F, 05B041F, 02B042F, 03B043F, 02B046F, 05

code_info

REF/UDI-DI/Lots: 71951-01/357599805005/02A289D, 03B082D, 02B082D, 02B109D, 03B251D, 04B251D, 01C073D, 01C084D, 02C087D,…

REF/UDI-DI/Lots: 71951-01/357599805005/02A289D, 03B082D, 02B082D, 02B109D, 03B251D, 04B251D, 01C073D, 01C084D, 02C087D, 01C143D, 03C152D, 03C166D, 01C174D, 03C222D, 01C256D, 02C313D, 01D018D, 02D093D, 02D129D; 71953-01/357599803001/01A198D, 02A198D, 03A198D, 04A198D, 05A198D, 01A202D, 04A202D, 01A204D, 02A203D, 02A205D, 03A205D, 01A211D, 02A211D, 03A210D, 02A212D, 04A218D, 05A218D, 06A218D, 01A219D, 04A225D, 05A225D, 01A231D, 03A231D, 02A232D, 06A232D, 02A240D, 02A248D, 01A259D, 01A260D, 04A262D, 03A266D, 01A267D, 02A268D, 03A268D, 02A280D, 01A281D, 01A283D, 02A283D, 01A290D, 02A297D, 02A298D, 03A296D, 02A303D, 02A304D, 04A325D, 01A328D, 03A325D, 02A340D, 03A344D, 02A351D, 03A350D, 01A352D, 03A352D, 02A358D, 01A364D, 02A363D, 01B007F, 02B007F, 01B008F, 01B011F, 03B012F, 01B012F, 01B014F, 05B013F, 01B015F, 04B013F, 02B013F, 11B021F, 02B034F, 02B035F, 04B034F, 04B035F, 06B034F, 07B034F, 02B036F, 05B035F, 01B036F, 01B039F, 03B039F, 03B036F, 03B041F, 05B041F, 02B042F, 03B043F, 02B046F, 05

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2414-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.