CLASS I ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report

ONE+ iOS CGM App recalled by Dexcom

Dexcom is recalling ONE+ iOS CGM App, distributed nationwide in the US. The recall was initiated on 24 Jul 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Code: UDI: SW14244 - 00386270004307

Quantity recalled39309

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2450-2025
FDA event ID: 97262
Recalling firm: Dexcom, San Diego, CA
Classification: Class I
Status: Ongoing
Recall initiated: 24 Jul 2025
FDA classified: 4 Sep 2025
Reported: 10 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

24 Jul 2025	Recall initiated by company
4 Sep 2025	Classified by FDA	+42 days
10 Sep 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

Where it was distributed

SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa SW12300 G7 iOS CGM App Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa SW14245 Dexcom ONE+ Android Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Israel, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden SW14244 D1G7 iOS Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot Code: UDI: SW14244 - 00386270004307

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 97262

This product is part of a recall event; the main page for the event is G7 Continuous Glucose Monitoring System Dexcom G7 CGM Android App recalled.

Reported	Class	Recall	Company	Reason	Where
10 Sep 2025	CLASS I	G7 Continuous Glucose Monitoring System Dexcom G7 CGM Android App recalled	Dexcom	Device Malfunction	Nationwide
10 Sep 2025	CLASS I	ONE+ Android CGM App recalled by Dexcom	Dexcom	Device Malfunction	Nationwide
10 Sep 2025	CLASS I	G7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App recalled	Dexcom	Device Malfunction	Nationwide
10 Sep 2025	CLASS I	G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled	Dexcom	Device Malfunction	Nationwide

More recalls from Dexcom

All 29

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	G7 Continuous Glucose Monitoring System Dexcom G7 US Retail recalled	Dexcom	Device Malfunction	CA
20 May 2026Device	CLASS II	ONE+ iOS CGM App recalled by Dexcom	Dexcom	Device Malfunction	Nationwide
20 May 2026Device	CLASS II	G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled	Dexcom	Device Malfunction	Nationwide
20 May 2026Device	CLASS II	G7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App recalled	Dexcom	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS I	G6 Continuous Glucose Monitoring System Dexcom G6 recalled	Dexcom	Device Malfunction	Nationwide

Other Insulin Pumps & Glucose Monitors recalls

All 465

Reported	Class	Recall	Company	Reason	Where
6 Oct 2026Device	ANNOUNCED	StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip	Nova Biomedical	Device Malfunction
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide