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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91756

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 13, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Abbott Diabetes Care, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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

Z-1273-2023
Recall number
Z-1273-2023
Initiated
February 13, 2023
Classification
Class I
Status
Ongoing
Quantity
336,085

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

U.S. Nationwide.

device · product 2 of 3

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

Z-1274-2023
Recall number
Z-1274-2023
Initiated
February 13, 2023
Classification
Class I
Status
Ongoing
Quantity
1,373,311

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

U.S. Nationwide.

device · product 3 of 3

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

Z-1275-2023
Recall number
Z-1275-2023
Initiated
February 13, 2023
Classification
Class I
Status
Ongoing
Quantity
1,534,532

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

U.S. Nationwide.