CLASS I ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report

FreeStyle Libre Reader recalled by Abbott Diabetes Care

Abbott Diabetes Care is recalling FreeStyle Libre Reader, distributed nationwide in the US. The recall was initiated on 13 Feb 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesREF/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, 02A279D; 71952-01/357599804008/01B179D, 02B176D, 02B174D, 03B174D, 02B172D, 03B172D, 01B172D, 02B163D, 01B163D, 02B159D, 02B160D, 01B160D, 04B154D, 05B154D, 02B154D, 04B152D, 03B152D, 01B147D, 02B147D, 03B144D, 01B131D, 01B133D, 02B132D, 01B132D, 03B131D, 02B131D, 01B125D, 02B124D, 05B124D, 05B120D, 01B118D, 02B118D, 01B116D, 02B116D, 03B116D, 04B112D, 02B112D, 04B111D, 01B111D, 02B111D, 01B110D, 01B103D, 02B103D, 01B100D, 01B098D, 03B097D, 03B096D, 02B096D, 04B095D, 02B095D, 03B095D, 01B086D, 01B088D, 02B088D, 01B085D, 02B085D, 03B085D, 02B084D, 01B076D, 04B070D, 02B069D, 02B064D, 03B064D, 01B064D, 01B053D, 02B053D, 02B050D, 03B041D, 02B037D, 03B037D, 04B037D, 05B034D, 01B033D, 02B033D, 03B032D, 06B021D, 01B018D, 01B014D, 02B004D, 01A346D, 05A344D, 01A343D, 04A340D, 03A340D, 02A338D, 01A330D, 02A329D, 02A322D, 01A322D, 02A321D, 01A316D, 03A316D, 02A315D, 03A311D, 02A311D, 03A310D, 01A311D, 01A308D, 01A302D, 01A301D, 01A296D, 02A296D, 01A289D, 03A288D, 03A275D, 02A275D, 01A272D, 01A273D, 02A272D, 03A269D, 03A263D, 01A258D, 01A256D, 02A256D, 02A255D, 01A255D, 01A253D, 01A254D, 01A252D, 03A233D, 03A225D, 01A223D, 01A224D, 02A220D, 03A220D, 01A220D, 01A210D, 02A210D, 02A209D, 01A206D, 02A206D, 03A206D, 04A205D; 71953-01/357599803001/06B074F, 01C346D, 03C340D, 01C341D, 02C340D, 01C340D, 02C334D, 04C334D, 01C334D, 01C327D, 01C332D, 01C326D, 01C325D, 02C325D, 01C322D, 02C321D, 03C320D, 01C318D, 01C317D, 01C313D, 02C312D, 01C307D, 01C308D, 03C305D, 01C305D, 02C305D, 01C300D, 02C298D, 01C299D, 01C298D, 03C294D, 06C292D, 02C294D, 04C292D, 02C287D, 01C283D, 03C279D, 02C278D, 01C273D, 04C276D, 01C272D, 01C276D, 08C271D, 01C266D, 03C270D, 02C265D, 02C262D, 02C257D, 03C257D, 01C257D, 02C256D, 03C256D, 02C255D, 03C251D, 02C250D, 01C249D, 02C245D, 01C245D, 04C243D, 02C242D, 02C243D, 01C242D, 01C243D, 03C242D, 04C241D, 02C237D, 03C238D, 01C237D, 03C236D, 02C236D, 01C228D, 02C229D, 03C224D, 01C227D, 01C224D, 02C224D, 01C223D, 02C223D, 03C213D, 01C207D, 01C209D, 02C208D, 03C207D, 01C201D, 02C199D, 05C199D, 03C199D, 03C196D, 02C193D, 01C194D, 01C188D, 02C188D, 01C186D, 01C182D, 01C181D, 02C181D, 02C172D, 05C165D, 03C165D, 01C161D, 01C159D, 03C159D, 01C146D, 05C146D, 01C144D, 02C145D, 02C143D, 01C140D, 02C140D, 03C140D, 04C140D, 04C138D, 01C137D, 01C138D, 01C133D, 01C136D, 02C136D, 03C133D, 02C133D, 02C130D, 03C129D, 03C126D, 03C123D, 03C117D, 02C116D, 02C112D, 01C109D, 02C080D, 01C075D, 01C077D, 02C074D, 03C075D, 02C073D, 03C074D, 01C074D, 01C034F, 02C032F, 01C028F, 02C031F, 03C031F, 03C028F, 02C025F, 02C013D, 01C014D, 03C013D, 01C011D, 01C012D, 02C010D, 02C005D, 01C006D, 03C005D, 02B363D, 01B362D, 02B362D, 01B356D, 04B356D, 05B356D, 02B356D, 04B354D, 03B351D, 04B352D, 06B349F, 02B344F, 01B343F, 04B302F, 01B342F, 02B342F, 02B343F, 01B341F, 02B341F, 01B341D, 02B341D, 01B302F, 01B340F, 02B340F, 03B302F, 04B301F, 01B337D, 01B337F, 02B337F, 01B336F, 02B336F, 01B335F, 03B335F, 02B333D, 01B334D, 01B333D, 01B308D, 02B328F, 01B327F, 03B326F, 04B326F, 01B323F, 01B326F, 06B322F, 01B305D, 07B322F, 05B322F, 01B313D, 03B312D, 03B313D, 02B312D, 01B310D, 01B308F, 01B309F, 01B309D, 02B308F, 03B306F, 01B306F, 02B306F, 01B306D, 02B305D, 01B289D, 02B289D, 01B288D, 02B229D, 02B216D, 01B215D, 02B211D, 02B208D, 01B208D, 01B205D, 01B207D, 03B203D, 02B203D, 03B109D, 05B082D, 02B083D, 02B082F, 04B082F, 02B081F, 03B081F, 02B078F, 05B078F, 01B077F, 05B076F, 02B076F, 05B075F, 04B074F, 05B071F, 01B071F, 02B046F, 05B043F, 06B046F, 09B046F, 02B042F, 03B043F, 05B046F, 03B041F, 05B041F, 03B036F, 01B036F, 01B039F, 03B039F, 02B036F, 05B035F, 02B035F, 04B034F, 04B035F, 06B034F, 07B034F, 02B034F, 11B021F, 02B013F, 04B013F, 01B015F, 01B012F, 01B014F, 05B013F, 03B012F, 01B008F, 01B011F, 01B007F, 02B007F, 01A364D, 02A363D, 02A358D, 01A352D, 03A352D, 02A351D, 03A350D, 03A344D, 02A340D, 01A328D, 03A325D, 04A325D, 02A304D, 02A303D, 02A297D, 02A298D, 03A296D, 01A290D, 02A283D, 01A283D, 01A281D, 02A280D, 03A268D, 01A267D, 02A268D, 03A266D, 04A262D, 01A259D, 01A260D, 02A248D, 02A240D, 06A232D, 02A232D, 01A231D, 03A231D, 04A225D, 05A225D, 01A219D, 04A218D, 05A218D, 06A218D, 02A212D, 01A211D, 02A211D, 03A210D, 02A205D, 03A205D, 01A204D, 02A203D, 04A202D, 01A202D, 04A198D, 05A198D, 01A198D, 02A198D, 03A198D

Quantity recalled1,534,532

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1275-2023
FDA event ID: 91756
Recalling firm: Abbott Diabetes Care, Alameda, CA
Classification: Class I
Status: Ongoing
Recall initiated: 13 Feb 2023
FDA classified: 6 Apr 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

13 Feb 2023	Recall initiated by company
6 Apr 2023	Classified by FDA	+52 days
12 Apr 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

Where it was distributed

U.S. Nationwide.

Nationwide

Questions about this recall

Is FreeStyle Libre Reader recalled?

Yes. Abbott Diabetes Care recalled FreeStyle Libre Reader on 13 Feb 2023. The recall is Class I and its status is Ongoing. Recall number Z-1275-2023.

Why was it recalled?

Which lots are affected?

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, 02A279D; 71952-01/357599804008/01B179D, 02B176D, 02B174D, 03B174D, 02B172D, 03B172D, 01B172D, 02B163D, 01B163D, 02B159D, 02B160D, 01B160D, 04B154D, 05B154D, 02B154D, 04B152D, 03B152D, 01B147D, 02B147D, 03B144D, 01B131D, 01B133D, 02B132D, 01B132D, 03B131D, 02B131D, 01B125D, 02B124D, 05B124D, 05B120D, 01B118D, 02B118D, 01B116D, 02B116D, 03B116D, 04B112D, 02B112D, 04B111D, 01B111D, 02B111D, 01B110D, 01B103D, 02B103D, 01B100D, 01B098D, 03B097D, 03B096D, 02B096D, 04B095D, 02B095D, 03B095D, 01B086D, 01B088D, 02B088D, 01B085D, 02B085D, 03B085D, 02B084D, 01B076D, 04B070D, 02B069D, 02B064D, 03B064D, 01B064D, 01B053D, 02B053D, 02B050D, 03B041D, 02B037D, 03B037D, 04B037D, 05B034D, 01B033D, 02B033D, 03B032D, 06B021D, 01B018D, 01B014D, 02B004D, 01A346D, 05A344D, 01A343D, 04A340D, 03A340D, 02A338D, 01A330D, 02A329D, 02A322D, 01A322D, 02A321D, 01A316D, 03A316D, 02A315D, 03A311D, 02A311D, 03A310D, 01A311D, 01A308D, 01A302D, 01A301D, 01A296D, 02A296D, 01A289D, 03A288D, 03A275D, 02A275D, 01A272D, 01A273D, 02A272D, 03A269D, 03A263D, 01A258D, 01A256D, 02A256D, 02A255D, 01A255D, 01A253D, 01A254D, 01A252D, 03A233D, 03A225D, 01A223D, 01A224D, 02A220D, 03A220D, 01A220D, 01A210D, 02A210D, 02A209D, 01A206D, 02A206D, 03A206D, 04A205D; 71953-01/357599803001/06B074F, 01C346D, 03C340D, 01C341D, 02C340D, 01C340D, 02C334D, 04C334D, 01C334D, 01C327D, 01C332D, 01C326D, 01C325D, 02C325D, 01C322D, 02C321D, 03C320D, 01C318D, 01C317D, 01C313D, 02C312D, 01C307D, 01C308D, 03C305D, 01C305D, 02C305D, 01C300D, 02C298D, 01C299D, 01C298D, 03C294D, 06C292D, 02C294D, 04C292D, 02C287D, 01C283D, 03C279D, 02C278D, 01C273D, 04C276D, 01C272D, 01C276D, 08C271D, 01C266D, 03C270D, 02C265D, 02C262D, 02C257D, 03C257D, 01C257D, 02C256D, 03C256D, 02C255D, 03C251D, 02C250D, 01C249D, 02C245D, 01C245D, 04C243D, 02C242D, 02C243D, 01C242D, 01C243D, 03C242D, 04C241D, 02C237D, 03C238D, 01C237D, 03C236D, 02C236D, 01C228D, 02C229D, 03C224D, 01C227D, 01C224D, 02C224D, 01C223D, 02C223D, 03C213D, 01C207D, 01C209D, 02C208D, 03C207D, 01C201D, 02C199D, 05C199D, 03C199D, 03C196D, 02C193D, 01C194D, 01C188D, 02C188D, 01C186D, 01C182D, 01C181D, 02C181D, 02C172D, 05C165D, 03C165D, 01C161D, 01C159D, 03C159D, 01C146D, 05C146D, 01C144D, 02C145D, 02C143D, 01C140D, 02C140D, 03C140D, 04C140D, 04C138D, 01C137D, 01C138D, 01C133D, 01C136D, 02C136D, 03C133D, 02C133D, 02C130D, 03C129D, 03C126D, 03C123D, 03C117D, 02C116D, 02C112D, 01C109D, 02C080D, 01C075D, 01C077D, 02C074D, 03C075D, 02C073D, 03C074D, 01C074D, 01C034F, 02C032F, 01C028F, 02C031F, 03C031F, 03C028F, 02C025F, 02C013D, 01C014D, 03C013D, 01C011D, 01C012D, 02C010D, 02C005D, 01C006D, 03C005D, 02B363D, 01B362D, 02B362D, 01B356D, 04B356D, 05B356D, 02B356D, 04B354D, 03B351D, 04B352D, 06B349F, 02B344F, 01B343F, 04B302F, 01B342F, 02B342F, 02B343F, 01B341F, 02B341F, 01B341D, 02B341D, 01B302F, 01B340F, 02B340F, 03B302F, 04B301F, 01B337D, 01B337F, 02B337F, 01B336F, 02B336F, 01B335F, 03B335F, 02B333D, 01B334D, 01B333D, 01B308D, 02B328F, 01B327F, 03B326F, 04B326F, 01B323F, 01B326F, 06B322F, 01B305D, 07B322F, 05B322F, 01B313D, 03B312D, 03B313D, 02B312D, 01B310D, 01B308F, 01B309F, 01B309D, 02B308F, 03B306F, 01B306F, 02B306F, 01B306D, 02B305D, 01B289D, 02B289D, 01B288D, 02B229D, 02B216D, 01B215D, 02B211D, 02B208D, 01B208D, 01B205D, 01B207D, 03B203D, 02B203D, 03B109D, 05B082D, 02B083D, 02B082F, 04B082F, 02B081F, 03B081F, 02B078F, 05B078F, 01B077F, 05B076F, 02B076F, 05B075F, 04B074F, 05B071F, 01B071F, 02B046F, 05B043F, 06B046F, 09B046F, 02B042F, 03B043F, 05B046F, 03B041F, 05B041F, 03B036F, 01B036F, 01B039F, 03B039F, 02B036F, 05B035F, 02B035F, 04B034F, 04B035F, 06B034F, 07B034F, 02B034F, 11B021F, 02B013F, 04B013F, 01B015F, 01B012F, 01B014F, 05B013F, 03B012F, 01B008F, 01B011F, 01B007F, 02B007F, 01A364D, 02A363D, 02A358D, 01A352D, 03A352D, 02A351D, 03A350D, 03A344D, 02A340D, 01A328D, 03A325D, 04A325D, 02A304D, 02A303D, 02A297D, 02A298D, 03A296D, 01A290D, 02A283D, 01A283D, 01A281D, 02A280D, 03A268D, 01A267D, 02A268D, 03A266D, 04A262D, 01A259D, 01A260D, 02A248D, 02A240D, 06A232D, 02A232D, 01A231D, 03A231D, 04A225D, 05A225D, 01A219D, 04A218D, 05A218D, 06A218D, 02A212D, 01A211D, 02A211D, 03A210D, 02A205D, 03A205D, 01A204D, 02A203D, 04A202D, 01A202D, 04A198D, 05A198D, 01A198D, 02A198D, 03A198D

Where was it sold?

U.S. Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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