Has Dexcom, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Dexcom, Inc., including 4 recalls and 0 warning letters.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

FDA Class II Recall: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System… by Dexcom, Inc.

Key facts

Recalling firm	Dexcom, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
Classification	Class II
Recall number	Z-2165-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

Key takeaway: Dexcom, Inc. recalled Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring (additional items listed in FDA's full record) on 2026-05-20. FDA classified this action as a Class II recall (recall number Z-2165-2026). Reason for recall: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the (additional items listed in FDA's full record). Recall status: Ongoing. This is a device-category FDA recall record.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Dexcom, Inc. and the affected product is described in FDA's record as: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring (additional items listed in FDA's full record). FDA's stated reason for the recall is: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-2165-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring (additional items listed in FDA's full record) -- and the recall number Z-2165-2026. If it matches, stop using or distributing it and contact Dexcom, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Dexcom, Inc.’s FDA history

Argus HQ has recorded 4 total FDA actions tied to Dexcom, Inc.: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Dexcom, Inc. had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Dexcom, Inc., including 4 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-2165-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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Full FDA history for Dexcom, Inc.

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 (2026). FDA Class II Recall: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System… by Dexcom, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-dexcom-inc-z-2165-2026

MLA

"FDA Class II Recall: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System… by Dexcom, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-dexcom-inc-z-2165-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System… by Dexcom, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-dexcom-inc-z-2165-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_dexcom_inc_z_2165_2026_2026,
  title = {FDA Class II Recall: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System… by Dexcom, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-dexcom-inc-z-2165-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗