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fda_recall · device_recall · critical

Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the Fre…

Event date
2023-04-12 00:00:00Z
Observed
2026-07-16 23:20:09Z
Source ID
Z-1273-2023
Payload hash
7711f75c8478fdc46d92dc3f…

Summary

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… Status: Ongoing.

Entities

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Frequently asked questions

Has Abbott Diabetes Care, Inc. had other FDA enforcement actions?
Yes. Argus HQ has recorded 10 total FDA actions tied to Abbott Diabetes Care, Inc.: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2023-04-12; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2023). Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the Fre…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-1273-2023
MLA
"Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the Fre…." Argus HQ Research, Digital Empire Holdings LLC, 2023, argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-1273-2023.
Chicago
Argus HQ Research. "Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the Fre…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-1273-2023.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_abbott_diabetes_care_inc_z_1273_2023_2023,
  title = {Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the Fre…},
  author = {{Argus HQ Research}},
  year = {2023},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-abbott-diabetes-care-inc-z-1273-2023},
  note = {Accessed: July 23, 2026}
}

Informational only. Not legal, financial, or medical advice.

Abbott Diabetes Care, Inc. — Class I recall: FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the Fre… · Argus HQ