CLASS II ONGOING Device recall · Reported 23 Aug 2023 · FDA Enforcement Report

FreeStyle Libre 2 Readers recalled by Abbott Diabetes Care

Abbott Diabetes Care is recalling FreeStyle Libre 2 Readers, distributed nationwide in the US. The recall was initiated on 12 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/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, 05B043F, 06B046F, 09B046F, 01B071F, 05B071F, 06B074F, 04B074F, 02B076F, 05B075F, 01B077F, 05B076F, 02B078F, 05B078F, 02B081F, 02B082F, 04B082F, 02B083D, 05B082D, 03B109D, 02B203D, 03B203D, 01B205D, 01B207D, 01B208D, 02B208D, 02B211D, 02B216D, 02B229D, 01B288D, 02B289D, 01B289D, 02B305D, 01B306F, 02B306F, 01B306D, 02B308F, 03B306F, 01B308F, 01B309F, 01B309D, 01B310D, 02B312D, 01B313D, 03B312D, 03B313D, 05B322F, 07B322F, 01B323F, 01B326F, 06B322F, 01B305D, 01B327F, 03B326F, 04B326F, 02B328F, 01B308D, 01B333D, 01B334D, 01B335F, 03B335F, 02B333D, 01B336F, 02B336F, 01B337F, 02B337F, 01B302F, 01B340F, 02B340F, 03B302F, 04B301F, 01B337D, 01B341F, 02B341F, 01B341D, 02B341D, 01B342F, 02B342F, 02B343F, 01B343F, 04B302F, 02B344F, 06B349F, 03B351D, 04B352D, 04B354D, 02B356D, 01B356D, 04B356D, 05B356D, 01B362D, 02B362D, 02B363D, 01C006D, 03C005D, 02C005D, 02C010D, 01C011D, 01C012D, 03C013D, 02C013D, 02C025F, 03C028F, 01C028F, 02C031F, 03C031F, 01C034F, 02C032F, 01C074D, 03C074D, 02C073D, 02C074D, 03C075D, 01C075D, 02C080D, 02C112D, 03C117D, 03C123D, 03C126D, 02C130D, 03C129D, 02C133D, 03C133D, 01C133D, 01C136D, 02C136D, 01C137D, 01C138D, 04C138D, 01C140D, 02C140D, 03C140D, 02C143D, 01C144D, 02C145D, 05C146D, 01C146D, 01C159D, 03C159D, 01C161D, 03C165D, 05C165D, 02C172D, 01C181D, 02C181D, 01C182D, 01C186D, 01C188D, 02C188D, 01C194D, 02C193D, 03C196D, 03C199D, 05C199D, 01C201D, 02C199D, 03C207D, 01C207D, 01C209D, 02C208D, 03C213D, 02C223D, 01C223D, 01C224D, 02C224D, 01C227D, 01C228D, 02C229D, 03C224D, 02C236D, 01C237D, 03C236D, 02C237D, 03C238D, 04C241D, 01C242D, 01C243D, 03C242D, 02C242D, 02C243D, 04C243D, 01C245D, 02C245D, 01C249D, 02C250D, 03C251D, 02C255D, 03C256D, 01C257D, 02C256D, 02C257D, 03C257D, 02C262D, 02C265D, 01C266D, 03C270D, 08C271D, 01C272D, 01C276D, 01C273D, 04C276D, 02C278D, 03C279D, 01C283D, 02C287D, 04C292D, 02C294D, 03C294D, 06C292D, 01C298D, 01C299D, 02C298D, 01C305D, 02C305D, 03C305D, 01C307D, 01C308D, 01C313D, 02C312D, 01C317D, 01C318D, 03C320D, 02C321D, 01C322D, 01C325D, 02C325D, 01C326D, 01C332D, 01C327D, 01C334D, 02C334D, 04C334D, 01C340D, 02C340D, 01C341D, 03C340D, 01C346D, 02C355D, 01D010D, 01D011D, 02D011D, 01D012D, 02D018D, 02D017D, 02D023D, 02D028D, 02D019D, 03D024D, 01D025D, 02D025D, 01D027D, 03D027D, 01D033D, 03D034D, 04D034D, 05D033D, 01D040D, 02D040D, 02D038D, 06D055D, 03D041D, 02D045D, 02D053D, 03D058D, 02D056D, 02D060D, 03D067D, 04D068D, 03D065D, 02D065D, 02D066D, 02D069D, 01D072D, 03D069D, 02D072D, 01D076D, 02D075D, 03D075D, 01D095D, 03D083D, 01D081D, 02D095D, 02D081D, 02D082D, 03D080D, 02D087D, 06D103D, 01D102D, 02D107D, 01D107D, 01D104D, 03D107D, 02D104D, 01D111D, 01D115D, 02D115D, 02D116D, 03D115D, 01D128D, 01D129D, 05D130D, 04D125D, 02D128D, 03D136D, 02D136D, 03D142D, 01D139D, 03D144D, 02D125D, 01D150D, 03D151D, 02D151D, 03D152D, 01D156D, 02D157D, 02D160D, 02D156D, 01D159D, 01D177D, 02D177D

Quantity recalled1,722,645

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-2414-2023
FDA event ID: 92708
Recalling firm: Abbott Diabetes Care, Alameda, CA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Jul 2023
FDA classified: 17 Aug 2023
Reported: 23 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

12 Jul 2023	Recall initiated by company
17 Aug 2023	Classified by FDA	+36 days
23 Aug 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

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

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

Where it was distributed

US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.

Nationwide California Florida Michigan New York Ohio Texas Utah Virginia

Questions about this recall

Is FreeStyle Libre 2 Readers recalled?

Yes. Abbott Diabetes Care recalled FreeStyle Libre 2 Readers on 12 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2414-2023.

Why was it recalled?

Which lots are affected?

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, 05B043F, 06B046F, 09B046F, 01B071F, 05B071F, 06B074F, 04B074F, 02B076F, 05B075F, 01B077F, 05B076F, 02B078F, 05B078F, 02B081F, 02B082F, 04B082F, 02B083D, 05B082D, 03B109D, 02B203D, 03B203D, 01B205D, 01B207D, 01B208D, 02B208D, 02B211D, 02B216D, 02B229D, 01B288D, 02B289D, 01B289D, 02B305D, 01B306F, 02B306F, 01B306D, 02B308F, 03B306F, 01B308F, 01B309F, 01B309D, 01B310D, 02B312D, 01B313D, 03B312D, 03B313D, 05B322F, 07B322F, 01B323F, 01B326F, 06B322F, 01B305D, 01B327F, 03B326F, 04B326F, 02B328F, 01B308D, 01B333D, 01B334D, 01B335F, 03B335F, 02B333D, 01B336F, 02B336F, 01B337F, 02B337F, 01B302F, 01B340F, 02B340F, 03B302F, 04B301F, 01B337D, 01B341F, 02B341F, 01B341D, 02B341D, 01B342F, 02B342F, 02B343F, 01B343F, 04B302F, 02B344F, 06B349F, 03B351D, 04B352D, 04B354D, 02B356D, 01B356D, 04B356D, 05B356D, 01B362D, 02B362D, 02B363D, 01C006D, 03C005D, 02C005D, 02C010D, 01C011D, 01C012D, 03C013D, 02C013D, 02C025F, 03C028F, 01C028F, 02C031F, 03C031F, 01C034F, 02C032F, 01C074D, 03C074D, 02C073D, 02C074D, 03C075D, 01C075D, 02C080D, 02C112D, 03C117D, 03C123D, 03C126D, 02C130D, 03C129D, 02C133D, 03C133D, 01C133D, 01C136D, 02C136D, 01C137D, 01C138D, 04C138D, 01C140D, 02C140D, 03C140D, 02C143D, 01C144D, 02C145D, 05C146D, 01C146D, 01C159D, 03C159D, 01C161D, 03C165D, 05C165D, 02C172D, 01C181D, 02C181D, 01C182D, 01C186D, 01C188D, 02C188D, 01C194D, 02C193D, 03C196D, 03C199D, 05C199D, 01C201D, 02C199D, 03C207D, 01C207D, 01C209D, 02C208D, 03C213D, 02C223D, 01C223D, 01C224D, 02C224D, 01C227D, 01C228D, 02C229D, 03C224D, 02C236D, 01C237D, 03C236D, 02C237D, 03C238D, 04C241D, 01C242D, 01C243D, 03C242D, 02C242D, 02C243D, 04C243D, 01C245D, 02C245D, 01C249D, 02C250D, 03C251D, 02C255D, 03C256D, 01C257D, 02C256D, 02C257D, 03C257D, 02C262D, 02C265D, 01C266D, 03C270D, 08C271D, 01C272D, 01C276D, 01C273D, 04C276D, 02C278D, 03C279D, 01C283D, 02C287D, 04C292D, 02C294D, 03C294D, 06C292D, 01C298D, 01C299D, 02C298D, 01C305D, 02C305D, 03C305D, 01C307D, 01C308D, 01C313D, 02C312D, 01C317D, 01C318D, 03C320D, 02C321D, 01C322D, 01C325D, 02C325D, 01C326D, 01C332D, 01C327D, 01C334D, 02C334D, 04C334D, 01C340D, 02C340D, 01C341D, 03C340D, 01C346D, 02C355D, 01D010D, 01D011D, 02D011D, 01D012D, 02D018D, 02D017D, 02D023D, 02D028D, 02D019D, 03D024D, 01D025D, 02D025D, 01D027D, 03D027D, 01D033D, 03D034D, 04D034D, 05D033D, 01D040D, 02D040D, 02D038D, 06D055D, 03D041D, 02D045D, 02D053D, 03D058D, 02D056D, 02D060D, 03D067D, 04D068D, 03D065D, 02D065D, 02D066D, 02D069D, 01D072D, 03D069D, 02D072D, 01D076D, 02D075D, 03D075D, 01D095D, 03D083D, 01D081D, 02D095D, 02D081D, 02D082D, 03D080D, 02D087D, 06D103D, 01D102D, 02D107D, 01D107D, 01D104D, 03D107D, 02D104D, 01D111D, 01D115D, 02D115D, 02D116D, 03D115D, 01D128D, 01D129D, 05D130D, 04D125D, 02D128D, 03D136D, 02D136D, 03D142D, 01D139D, 03D144D, 02D125D, 01D150D, 03D151D, 02D151D, 03D152D, 01D156D, 02D157D, 02D160D, 02D156D, 01D159D, 01D177D, 02D177D

Where was it sold?

US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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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12 Apr 2023Device	CLASS I	FreeStyle Libre Reader recalled by Abbott Diabetes Care	Abbott Diabetes Care	Device Malfunction	Nationwide
12 Apr 2023Device	CLASS I	FreeStyle Libre Reader recalled by Abbott Diabetes Care	Abbott Diabetes Care	Device Malfunction	Nationwide
12 Apr 2023Device	CLASS I	FreeStyle Libre Reader recalled by Abbott Diabetes Care	Abbott Diabetes Care	Device Malfunction	Nationwide
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