Z-1273-2023Class I

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

Name: Z-1273-2023 FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose...
Creator: Abbott Diabetes Care, Inc.
Published: 2023-02-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-02-13 / Open, Classified / root cause: design

FDA source

Abbott Diabetes Care, Inc. began a recall of FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System on 2023-02-13. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1273-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-02-13
Posted: 2023-04-06
Recalling firm: Abbott Medical
Product: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
Product code: PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
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.
Root cause tag: design
FDA root cause: 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: 336,085
Distribution: U.S. Nationwide.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1273-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1273-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-06
Z-1274-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-06
Z-1275-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-04-06

Product code PZE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)