Stelo Glucose Biosensor (2pk) UPC STP-XN-002Recalls & reported problems
Dexcom, Inc. · Stelo Glucose Biosensor US (2pk) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00386270004406), received between May 15, 2025 and May 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2025Break; Break
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: No Clinical Signs, Symptoms or Conditions
MAUDE report 22032164 ↗MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A DETACHED OR MISSING 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 22031410 ↗MalfunctionMay 15, 2025Break; Break
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 22027013 ↗
Other Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter devices
- Stelo Glucose Biosensor (2pk) STP-XN-002Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter612 reports
- Stelo Glucose Biosensor (1pk) STP-XN-001Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter551 reports
- Stelo Biosensor 9500-174Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter290 reports
- Lingo 77263Abbott Diabetes Care Inc · Integrated continuous glucose monitor for non-intensive glucose monitoring, Over-The-Counter33 reports
- Stelo Glucose Biosensor (2pk) STP-XN-003Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter4 reports
- Dexcom Stelo iOS Mobile App SW14116Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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