CLASS I ONGOING Device recall · Reported 25 Jun 2025 · FDA Enforcement Report
One+ Continuous Glucose Monitoring System recalled by Dexcom
Dexcom is recalling One+ Continuous Glucose Monitoring System, distributed nationwide in the US. The recall was initiated on 12 May 2025 and the FDA has classified it as Class I.
Check your package
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-1945-2025
- FDA event ID
- 96743
- Recalling firm
- Dexcom, San Diego, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 May 2025
- FDA classified
- 16 Jun 2025
- Reported
- 25 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 12 May 2025 | Recall initiated by company | |
| 16 Jun 2025 | Classified by FDA | +35 days |
| 25 Jun 2025 | 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
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
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 One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
Where it was distributed
worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Questions about this recall
Why was it recalled?
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
Which lots are affected?
All Lots/ UDI: STK-D7-013 - 00386270003812; STK-D7-014 - 00386270003843; STK-D7-103 - 00386270003836
Where was it sold?
worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
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
3 other products · FDA event 96743| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | One Continuous Glucose Monitoring System, SKUs recalled by Dexcom | Dexcom | Device Malfunction | Nationwide | |
| CLASS I | G6 Glucose Receiver, SKUs recalled by Dexcom | Dexcom | Device Malfunction | Nationwide | |
| CLASS I | G7 Glucose Receiver, SKUs recalled by Dexcom | Dexcom | Device Malfunction | Nationwide |
More recalls from Dexcom
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 US Retail recalled | Dexcom | Device Malfunction | CA |
| Device | CLASS II | ONE+ iOS CGM App recalled by Dexcom | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App recalled | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS I | G6 Continuous Glucose Monitoring System Dexcom G6 recalled | Dexcom | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 467| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |