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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Abbott Diabetes Care, Inc.: 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.

Agency Publication Date: April 6, 2023
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Affected Products

Product: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System

REF/UDI-DI/Lot: 71525-01/357599000219/02Y702D, 01Y699D, 02Y699D, 01Y698D, 02Y697D, 04Y690D, 03Y690D, 01Y683D, 02Y683D, 01Y674D, 02Y672D, 01Y669D, 02Y666D, 01Y659D, 02Y658D, 02Y656D, 04Y655D, 01Y655D, 01Y652D, 02Y653D, 03Y653D, 03Y651D, 01Y641D, 02Y638D, 01Y637D, 02Y635D, 01Y629D, 03Y628D, 01Y628D, 02Y628D, 02Y621D, 02Y622D, 02Y620D, 02Y608D, 04Y608D, 01Y608D, 01Y603D, 03Y599D, 04Y600D, 02Y596D, 06Y596D, 03Y596D, 07Y547D, 07Y546D, 08Y546D, 05Y540D, 06Y538D, 05Y537D, 03Y536D, 04Y523D, 02Y522D, 02Y519D, 02Y512D, 01Y512D, 01Y511D, 02Y510D, 01Y505D, 02Y504D, 04Y355D, 02Y355D, 01Y352D, 01Y349D, 03Y348D, 01Y348D, 02Y348D, 01Y339D, 01Y335D, 02Y334D, 02Y335D, 03Y314D, 01Y313D, 02Y312D, 01Y312D, 02Y311D, 01Y311D, 02Y310D, 04Y310D, 02Y307D, 03Y307D, 01Y304D, 02Y303D, 02Y304D; 71701-01/357599000226/01Y702D, 01Y694D, 03Y693D, 02Y686D, 03Y683D, 02Y574D, 01Y563D, 02Y563D, 01Y564D, 03Y562D, 01Y552D, 02Y552D, 06Y550D, 05Y539D, 05Y538D, 06Y537D, 01Y536D, 01Y532D, 02Y531D, 03Y522D, 02Y518D, 02Y511D, 01Y508D, 02Y505D, 04Y356D, 01Y356D, 02Y356D, 01Y321D, 01Y320D, 02Y320D, 01Y317D, 02Y317D; 71739-01/357599000240/03Y754D, 03Y734D, 01Y705D, 01Y671D

Lot Numbers:
71525-01
Product: FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System

REF/UDI-DI/Lot: 71936-01/357599000981/01C083D, 02C054D, 03C033D, 03B356D, 01B320D, 03B266D, 02B250D, 02B181D, 01B161D, 01B096D, 05B081D, 03B035D, 02A314D, 02A238D, 02A191D, 01A160D, 03A132D, 01A093D, 02A085D, 01A074D, 02A064D, 02A063D, 02A016D, 04Z351D, 01Z318D, 01Z282D, 01Z246D, 04Z191D, 03Z178D, 03Z151D, 03Z128D, 05Z115D, 03Z057D; 71937-01/357599000974/02B099D, 01B082D, 02A098D, 03A097D, 02A094D, 02A092D, 03A093D, 04A091D, 01A091D, 02A056D, 01A055D, 05A050D, 01A049D, 01Z360D, 01Z352D, 01Z346D, 02Z346D, 01Z344D, 02Z339D, 01Z338D, 03Z337D, 03Z336D, 03Z318D, 01Z311D, 03Z309D, 01Z305D, 05Z304D, 03Z303D, 02Z290D, 03Z290D, 02Z289D, 03Z246D, 01Z238D, 02Z178D, 03Z177D, 02Z177D, 03Z172D, 05Z172D, 02Z163D, 02Z151D, 03Z116D, 01Z116D, 01Z102D, 04Z083D, 02Z057D, 01Z056D, 02Z036D, 01Z024D, 01Y861D, 02Y854D, 03Y845D, 02Y845D, 01Y845D, 03Y839D, 01Y838D, 06Y830D, 03Y820D, 01Y820D, 02Y811D, 03Y811D, 01Y811D, 06Y795D, 05Y795D, 02Y791D, 03Y790D, 02Y789D, 01Y782D, 02Y782D, 01Y781D, 01Y776D, 01Y763D, 02Y762D, 02Y763D; 71938-01/357599002008/04C216D, 02C189D, 04C160D, 01C116D, 04C059D, 01C045D, 01C040D, 01C041D, 01C038D, 02C040D, 01C037D, 02C028D, 02C025D, 02C020D, 02C021D, 02C014D, 03C007D, 02B344D, 03B348D, 01B347D, 01B344D, 03B341D, 01B324D, 01B322D, 03B321D, 02B317D, 02B308D, 04B308D, 01B307D, 03B289D, 01B287D, 01B286D, 02B280D, 01B265D, 01B256D, 02B254D, 01B252D, 02B252D, 02B242D, 03B237D, 01B235D, 01B218D, 01B216D, 04B211D, 01B209D, 02B202D, 01B202D, 03B194D, 01B194D, 02B190D, 03B190D, 01B189D, 01B190D, 02B189D, 05B187D, 02B187D, 01B166D, 01B167D, 02B167D, 01B165D, 01B162D, 03B160D, 01B159D, 03B158D, 01B152D, 02B152D, 02B148D, 01B148D, 01B146D, 02B146D, 01B145D, 04B134D, 01B134D, 01B130D, 03B127D, 07B120D, 02B106D, 02B105D, 03B105D, 05B099D, 03B090D, 04B090D, 01B081D, 04B076D, 02B070D, 02B074D, 02B068D, 02B067D, 02B065D, 01B063D, 02B062D, 03B062D, 04B040D, 01B040D, 01B034D, 01B035D, 03B034D, 02B027D, 02B026D, 01B015D, 04B015D, 01B013D, 03B012D, 04B012D, 01B012D, 03B009D, 01A366D, 01A351D, 01A347D, 02A339D, 01A338D, 01A337D, 01A329D, 01A324D, 02A324D, 02A317D, 03A317D, 04A302D, 01A279D, 03A279D, 06A277D, 01A262D, 02A261D, 01A248D, 01A247D, 03A244D, 04A244D, 01A240D, 04A238D, 01A238D, 04A232D, 01A232D, 03A224D, 04A197D, 04A196D, 01A196D, 01A197D, 03A191D, 01A188D, 01A178D, 01A181D, 02A181D, 03A181D, 02A176D, 05A176D, 01A175D, 02A175D, 03A176D, 04A176D, 05A168D, 02A164D, 02A141D, 02A142D, 04A140D, 04A142D, 02A140D, 01A137D, 01A136D, 02A136D, 01A135D, 01A134D, 01A132D, 02A133D, 01A133D, 06A132D, 01A125D, 02A125D, 04A122D, 03A122D, 01A121D, 02A120D, 01A120D, 02A118D, 02A119D, 01A116D, 02A115D, 01A104D, 01A100D, 04A099D, 02A099D, 01A094D, 01A097D, 02A097D, 01A092D, 03A092D, 04A090D, 05A090D, 03A079D, 04A079D, 03A077D, 04A077D, 01A076D, 03A072D, 04A064D, 01A064D, 05A059D, 01A059D, 04A058D, 05A058D, 01A057D, 02A057D, 03A056D, 03A050D, 03A036D, 01A034D, 02A034D, 02A029D, 01A030D, 02A030D, 01A028D, 01A029D, 02A028D, 03A030D, 01A015D, 01A013D, 01A014D, 03A010D, 02A008D, 01A009D, 01A008D, 02A007D, 01A003D, 07Z351D, 01Z345D, 03Z345D, 01Z339D, 02Z338D, 02Z331D, 01Z331D, 03Z330D, 04Z330D, 05Z330D, 04Z326D, 02Z326D, 02Z325D, 01Z326D, 01Z325D, 03Z319D, 05Z319D, 04Z319D, 02Z303D, 03Z281D, 02Z275D, 01Z266D, 01Z262D, 02Z261D, 03Z261D, 02Z259D, 01Z252D, 01Z241D, 03Z241D, 04Z228D, 02Z227D, 02Z226D, 01Z224D, 02Z221D, 02Z220D, 01Z217D, 04Z199D, 04Z197D, 01Z197D, 02Z191D, 02Z189D, 01Z184D, 02Z179D, 04Z179D, 01Z175D, 01Z170D, 02Z171D, 04Z165D, 05Z165D, 01Z165D, 04Z158D, 02Z155D, 01Z150D, 01Z142D, 03Z141D, 01Z138D, 04Z137D, 01Z136D, 01Z135D, 01Z133D, 01Z128D, 01Z126D, 02Z121D, 01Z112D, 03Z109D, 01Z109D, 01Z108D, 02Z107D, 02Z099D, 01Z098D, 03Z095D, 03Z094D, 01Z094D, 02Z092D, 02Z093D, 01Z087D, 03Z086D, 04Z086D, 02Z085D, 01Z083D, 03Z083D, 02Z082D, 03Z081D, 01Z081D, 02Z080D, 01Z078D, 02Z073D, 03Z072D, 03Z073D, 03Z070D, 02Z067D, 04Z066D, 05Z066D, 02Z060D, 03Z060D, 02Z059D, 01Z058D, 04Z057D, 03Z053D, 01Z050D, 02Z050D, 04Z045D, 01Z044D, 01Z045D, 02Z045D, 01Z043D, 02Z044D, 01Z042D, 02Z039D, 03Z039D, 01Z039D, 01Z038D, 02Z037D, 01Z035D, 01Z031D, 02Z030D, 01Z030D, 03Z029D, 01Z025D, 02Z025D, 04Z024D, 02Z024D, 03Z024D, 01Z023D, 02Z022D, 03Z022D, 02Z018D, 01Z021D, 02Z016D, 03Z017D, 01Z016D, 03Z015D, 01Z008D, 01Z009D, 02Z008D, 02Z007D, 02Z002D, 03Z002D, 01Z002D, 01Y865D, 02Y865D, 03Y862D, 02Y860D, 01Y860D, 02Y855D, 05Y854D, 01Y854D, 01Y855D, 04Y854D, 04Y851D, 05Y851D, 02Y848D, 01Y847D, 01Y834D, 03Y834D, 02Y833D, 01Y833D, 05Y832D, 02Y831D, 01Y831D, 03Y819D, 04Y819D, 02Y810D, 03Y809D, 04Y809D, 01Y803D, 02Y803D, 03Y802D, 04Y802D, 01Y788D, 02Y788D, 01Y785D, 01Y777D, 02Y776D, 01Y775D, 01Y774D, 01Y761D, 02Y761D, 03Y760D

Lot Numbers:
71936-01
Product: FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

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

Lot Numbers:
71951-01

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91756
Status: Active
Manufacturer: Abbott Diabetes Care, Inc.
Manufactured In: United States
Units Affected: 3 products (336,085; 1,373,311; 1,534,532)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.