Stelo Glucose Biosensor (2pk) STP-XN-003Recalls & reported problems
Dexcom, Inc. · Stelo Glucose Biosensor US (2pk) - Amazon · Class 2
All models of Stelo Glucose Biosensor (2pk) (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00386270004857), received between Aug 26, 2025 and May 1, 2026 — classified as 4 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 Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT THE NEEDLE WAS BROKEN. THE SENSOR WAS INSERTED 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 25057802 ↗MalfunctionAug 26, 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: Foreign Body In Patient
MAUDE report 22893261 ↗MalfunctionAug 26, 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 22893170 ↗MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A DETACHED OR MISSING 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 22893012 ↗
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
- Dexcom Stelo iOS Mobile App SW14116Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter3 reports
- Stelo Glucose Biosensor (2pk) UPC STP-XN-002Dexcom, 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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