Dexcom ONE+ iOS CGM App Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Dexcom, Inc. is recalling 70,212 units of the Dexcom ONE+ iOS CGM App (SW14244, versions 1.5.0 and 1.6.0) due to a software defect that may delay glucose notifications.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 3, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, devices.
What Happened
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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Which Products Are Affected
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 Lot Code: SW14244 versions 1.5.0 and 1.6.0 - UDI-DI: 00386270004307 Product quantity: 70,212 units Recall Number: Z-2165-2026 Classification: Class II Distribution: International, including the countries of Andorra, Australia, Belgium, Bulgaria, Czech Republic, Estonia, France, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Malaysia, Monaco, Netherlands, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Spain, Sweden, United Kingdom.
What You Should Do
The recall is ongoing and was initiated voluntarily by the firm. Consumers should refer to the recalling firm for further information.
Why This Matters
The defect creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event or make treatment decisions based on outdated glucose information.
Source
FDA recall Z-2165-2026, Dexcom, Inc., San Diego, CA. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,762 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.