CLASS II ONGOING Device recall · Reported 26 Feb 2025 · FDA Enforcement Report

G6, Continuous Glucose Monitoring System recalled by Dexcom

Dexcom is recalling Dexcom G6, Continuous Glucose Monitoring System, distributed nationwide in the US. The recall was initiated on 27 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Serial Numbers/UDI: 00386270000590

Quantity recalledN/A

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-1203-2025
FDA event ID: 96091
Recalling firm: Dexcom, San Diego, CA
Classification: Class II
Status: Ongoing
Recall initiated: 27 Jan 2025
FDA classified: 20 Feb 2025
Reported: 26 Feb 2025
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

27 Jan 2025	Recall initiated by company
20 Feb 2025	Classified by FDA	+24 days
26 Feb 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

Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.

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

Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001

Where it was distributed

Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.

Nationwide California Florida Georgia Minnesota New Hampshire New Jersey Pennsylvania Puerto Rico South Carolina Texas

Questions about this recall

Is G6, Continuous Glucose Monitoring System recalled?

Yes. Dexcom recalled G6, Continuous Glucose Monitoring System on 27 Jan 2025. The recall is Class II and its status is Ongoing. Recall number Z-1203-2025.

Why was it recalled?

Which lots are affected?

All Serial Numbers/UDI: 00386270000590

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	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 459

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	Nationwide
15 Jul 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Lead & Heavy Metals	Nationwide
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Lead & Heavy Metals	Nationwide