CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report

ONE+ iOS CGM App recalled by Dexcom

Dexcom is recalling Dexcom ONE+ iOS CGM App, distributed nationwide in the US. The recall was initiated on 14 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: SW14244 versions 1.5.0 and 1.6.0 - UDI-DI: 00386270004307

Quantity recalled70212

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-2165-2026
FDA event ID: 98639
Recalling firm: Dexcom, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Apr 2026
FDA classified: 11 May 2026
Reported: 20 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

14 Apr 2026	Recall initiated by company
11 May 2026	Classified by FDA	+27 days
20 May 2026	Published in enforcement report	+9 days

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

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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

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 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

Where it was distributed

SW12300 & SW13355 Dexcom G7 iOS and watchOS app versions 2.9.0 through 2.11.2: Worldwide - US Nationwide including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Austria, Australia, Belgium, Bahrain, Canada, Czech Republic, Germany, Denmark, Estonia, Finland, France, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, Kuwait, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom. SW14245 Dexcom ONE iOS App versions 1.5.0 and 1.6.0 - Only International distribution to 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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Is ONE+ iOS CGM App recalled?

Yes. Dexcom recalled ONE+ iOS CGM App on 14 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2165-2026.

Why was it recalled?

Which lots are affected?

Lot Code: SW14244 versions 1.5.0 and 1.6.0 - UDI-DI: 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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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	Sterility	CA
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
10 Sep 2025Device	CLASS I	G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled	Dexcom	Lead & Heavy Metals	Nationwide

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