• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall FreeStyle Libre 14 day Flash Glucose Monitoring System

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 1 Device Recall FreeStyle Libre 14 day Flash Glucose Monitoring System see related information
Date Initiated by Firm February 13, 2023
Date Posted April 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-1274-2023
Recall Event ID 91756
PMA Number P160030S017 
Product Classification Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated - Product Code PZE
Product FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
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
Recalling Firm/
Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information Contact Lindsy Delco
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action On 02/13/2023, correction notices were mailed or emailed to customers, health care professionals, and distribution partners who were asked to do the following: To determine if the Reader needs to be replaced, answer these questions: Does Reader appear damaged, cracked, or swollen? Has Reader been too hot to hold? Is it no longer able to hold a charge? If NO to all, perform a Reader Test. See www.FreeStyleBattery.com If yes or if the test failed, discontinue use and call Customer Service for replacement. - Don't expose the Reader, power adapter or yellow USB cable to liquids. - Store the Reader between -4 F and 140 F. - Avoid getting dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB port. - Check USB port and make sure it is dry and free of debris. - Use only the Abbott provided power adapter and yellow USB cable that came with your Reader and check they are free from damage. - Ensure you can access the power adapter and quickly disconnect it to prevent the potential risk of electrical shock. - Don't force or bend the end of the yellow USB cable into the Reader's USB port. - If the Reader is dropped or subjected to impact, perform a Reader Test to confirm it is still working properly. Customers are asked to acknowledge they have read and understood the actions contained in the letter by clicking the link or scanning the QR code. Health Care Professions were asked to ask their patients the questions above. Distribution Partners were asked to forward the correction notice and response form to customers. Customers with questions can contact Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time excluding major holidays.
Quantity in Commerce 1,373,311
Distribution U.S. Nationwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = PZE and Original Applicant = ABBOTT DIABETES CARE INC.