Dexcom G7 GSS (161) STP-AT-012Recalls & reported problems
Dexcom, Inc. · G7 US Retail Sensor/Transmitter 1-pack · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is a Dexcom G7 sensor sold at retail. Its reports mostly describe wireless disconnects, sensors detaching and low or high readings. There are 48,169 reports, including 5 deaths and 1,385 injuries. One recall, started in May 2026, is open: some sensor lots meant for destruction were stolen during disposal and later sold. Reports rose to 31,087 in the last 12 months, from 16,012 before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48,180
- Deaths reported
- 5
- Injuries reported
- 1,385
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 48,180 adverse event reports that list this exact device (DI 00386270004109), received between Dec 27, 2023 and Sep 30, 2026 — classified as 5 deaths, 1,385 injuries, 46,790 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (19,507 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Wireless Communication Problem19,507
- Detachment of Device or Device Component10,100
- Low Readings9,368
- High Readings2,715
- Appropriate Device Problem Term/Code Not Available2,389
- Break1,760
- Incorrect, Inadequate or Imprecise Result or Readings1,083
- Premature End-of-Life Indicator724
Patient problems
- No Clinical Signs, Symptoms or Conditions34,482
- Hyperglycemia9,715
- Hypoglycemia2,314
- Foreign Body In Patient1,065
- Loss of consciousness287
- Vomiting246
- Nausea216
- Elevated Ketones/ Diabetic Ketoacidosis211
Recent adverse event reports
The 25 most recent of 48,180 reports, 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 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 ↗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 ↗MalfunctionSep 18, 2026Wireless Communication Problem
It was reported that "Signal Loss" occurred. No product or data was provided for investigation. The allegation and the probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825443 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
It was reported that a broken sensor wire occurred. Data was received but not investigated as data will not confirm the issue. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: Foreign Body In Patient
MAUDE report 50820858 ↗MalfunctionSep 16, 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 50789626 ↗MalfunctionSep 11, 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 50736128 ↗MalfunctionSep 11, 2026Appropriate Device Problem Term/Code Not Available
It was reported that unspecified wearable issue occured.¿Analysis indicated the lot number for this complaint record is associated with the third-party unauthorized product release and use of non-conforming product that was scrapped by Dexcom. The third party acted as an unauthorized remanufacturer under 21 CFR 820.3 and engaged in prohibited actions under 21 U.S.C. § 331 without Dexcom¿s knowledge or approval. This is documented in CAPA-000611 and FAS-SD-26-002. No injury or medical intervention was reported. No further investigation is required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734541 ↗MalfunctionSep 10, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722783 ↗MalfunctionSep 10, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722192 ↗MalfunctionSep 9, 2026Inappropriate or Unexpected Reset
It was reported that there was a sensor not active message; during sensor session. Data was provided for investigation. Confirmation of the complaint was undetermined. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691261 ↗MalfunctionSep 8, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679154 ↗MalfunctionSep 4, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted into the arm on (b)(6) 2026. Data was received but not investigated as data will not confirm the issue. 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 50612550 ↗MalfunctionSep 2, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576309 ↗MalfunctionSep 2, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571816 ↗MalfunctionSep 2, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569883 ↗MalfunctionSep 1, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548103 ↗MalfunctionSep 1, 2026Appropriate Device Problem Term/Code Not Available
It was reported that Wearable not working occurred. Analysis indicated the lot number for this complaint record is associated with the third-party unauthorized product release and use of non-conforming product that was scrapped by Dexcom. The third party acted as an unauthorized remanufacturer under 21 CFR 820.3 and engaged in prohibited actions under 21 U.S.C. § 331 without Dexcom¿s knowledge or approval. This is documented in CAPA-000611 and FAS-SD-26-002. No injury or medical intervention was reported. No further investigation is required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544843 ↗MalfunctionAug 31, 2026Connection Problem
It was reported that the transmitter unpaired itself. Data was provided for investigation. Confirmation of the complaint was undetermined. The probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532225 ↗MalfunctionAug 31, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531810 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50523770 ↗MalfunctionAug 28, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509629 ↗MalfunctionAug 28, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509043 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.