Dexcom G7 GSS (161)Recalls & reported problems across all models
Dexcom, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Dexcom G7 GSS (161) model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 141,244
- Deaths reported
- 5
- Injuries reported
- 2,945
- Recalls
- 1
We found 4 models of Dexcom G7 GSS (161) by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 141,244 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2023 and Sep 30, 2026 — classified as 5 deaths, 2,945 injuries, 138,293 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (48,844 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Dexcom G7 GSS (161) recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 27, 2026Open, Classified
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
Z-2574-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported Dexcom G7 GSS (161) problems
Device problems
- Wireless Communication Problem48,844
- Detachment of Device or Device Component45,633
- Low Readings19,400
- Incorrect, Inadequate or Imprecise Result or Readings9,911
- Break6,461
- High Readings5,077
- Appropriate Device Problem Term/Code Not Available3,113
- Premature End-of-Life Indicator1,700
Patient problems
- No Clinical Signs, Symptoms or Conditions105,671
- Hyperglycemia26,210
- Hypoglycemia5,011
- Foreign Body In Patient3,066
- Loss of consciousness676
- Nausea578
- Vomiting567
- Dizziness524
Dexcom G7 GSS (161) models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dexcom G7 GSS (161) 9500-161Integrated Continuous Glucose Monitoring System, Factory Calibrated70,146 reports
- Dexcom G7 GSS (161) STP-AT-012Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall5 deaths48,180 reports
- Dexcom G7 GSS (161) STP-AT-013Integrated Continuous Glucose Monitoring System, Factory Calibrated16,695 reports
- Dexcom G7 GSS (161) STP-AT-011Integrated Continuous Glucose Monitoring System, Factory Calibrated6,223 reports
Recent Dexcom G7 GSS (161) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Wireless Communication Problem
It was reported that a signal loss occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952051 ↗MalfunctionSep 30, 2026Wireless Communication Problem
It was reported that a signal loss occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951748 ↗MalfunctionSep 30, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949897 ↗MalfunctionSep 29, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939047 ↗MalfunctionSep 29, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938575 ↗MalfunctionSep 29, 2026Wireless Communication Problem
It was reported that a pairing issue occurred. Performance data was reviewed. A pairing issue was not found within the investigation window. The allegation was not confirmed. However, signal loss over an hour was found in connection to the reported allegation. The probable cause of the signal loss was determined to be the transmitter and app were unable to establish a connection. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932137 ↗OtherSep 25, 2026Defective Alarm
It was reported that an alert/notification settings issue occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No serious or prolonged patient harm or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895750 ↗MalfunctionSep 24, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. It was indicated that a sensor insertion into the abdomen occurred on (b)(6)-2026, which is an off-label misuse of the device. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined, and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887934 ↗MalfunctionSep 24, 2026Wireless Communication Problem
It was reported that a signal loss occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885439 ↗MalfunctionSep 23, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876241 ↗MalfunctionSep 23, 2026Break
It was reported that a broken sensor wire occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871667 ↗MalfunctionSep 23, 2026Wireless Communication Problem
It was reported that a signal loss occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871337 ↗MalfunctionSep 22, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. The sensor was inserted into the arm on (b)(6) 2026. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857373 ↗MalfunctionSep 22, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849387 ↗MalfunctionSep 21, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846299 ↗
Other Dexcom, Inc. products
- Dexcom G613 models · 637,302 reports · 7 recalls
- Dexcom G6 Transmitter2 models · 469,968 reports
- Dexcom G732 models · 325,909 reports · 8 recalls
- Dexcom G521 models · 206,314 reports · 1 recall
- Dexcom G4 Platinum41 models · 119,308 reports · 2 recalls
- Dexcom G7 Receiver4 models · 33,732 reports · 1 recall
- Dexcom G7 GSS (160)4 models · 33,558 reports
- Dexcom G5 Mobile Receiver3 models · 26,327 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page