Stelo Glucose Biosensor (2pk) STP-XN-002Recalls & reported problems
Dexcom, Inc. · Stelo Glucose Biosensor US (2pk) · Class 2
Quick summary
This Dexcom Stelo glucose biosensor is an over-the-counter continuous glucose monitor. Of the 602 reports naming it, most describe parts of the sensor detaching or breaking, and some list a foreign body in the patient. The reports include 24 injuries and no deaths, and reports rose from 234 in the previous 12 months to 368 in the latest 12 months. No recalls name this device.
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
- 612
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 612 adverse event reports that list this exact device (DI 00386270004383), received between May 9, 2025 and Sep 30, 2026 — classified as 25 injuries, 587 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (367 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component367
- Break112
- Appropriate Device Problem Term/Code Not Available92
- Adverse Event Without Identified Device or Use Problem20
- Unintended Electrical Shock6
- No Audible Alarm5
- Defective Alarm3
- Display or Visual Feedback Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions502
- Foreign Body In Patient81
- Pain19
- Erythema17
- Bacterial Infection14
- Skin Inflammation/ Irritation11
- Abscess8
- Foreign Body Reaction6
Recent adverse event reports
The 25 most recent of 612 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954962 ↗MalfunctionSep 30, 2026Detachment 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 50951457 ↗MalfunctionSep 30, 2026Detachment 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 50951137 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939738 ↗MalfunctionSep 29, 2026Break
Patient problems: Foreign Body In Patient; Pain
MAUDE report 50938530 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: Foreign Body In Patient; Pain
MAUDE report 50926421 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50552538 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 50551695 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50546279 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519115 ↗MalfunctionAug 27, 2026Detachment 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 50479847 ↗MalfunctionAug 26, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463594 ↗MalfunctionAug 26, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50461428 ↗MalfunctionAug 26, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458394 ↗InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported via email that a skin reaction occurred. Additional information indicated that a skin reaction occurred at the sensor insertion site following sensor insertion into the arm on (b)(6)2026. The customer reported, "I had an issue with the sensor early Wednesday morning when I was awakened in a lot of pain. The back of my arm kept hurting bad enough that I had to remove the sensor. There was a knot present, pain, redness, and a fever at the site. Since the redness, swelling, pain, and fever have gotten worse to the point where I am now at an ER." The reported skin reaction included pain, redness, swelling, a knot at the insertion site, and fever. Due to worsening symptoms, the customer sought evaluation and treatment in the Emergency Department (ER). No treatment information was provided, and no additional details regarding the event or outcome were available at the time of the report. No product or data was provided for investigation. Problem could not be confirmed and probable cause cannot be determined. No additional patient or event information is available.
Patient problems: Abscess; Bacterial Infection; Erythema; Fever; Pain; Skin Inflammation/ Irritation
MAUDE report 50262172 ↗MalfunctionAug 7, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173951 ↗MalfunctionAug 6, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165562 ↗MalfunctionAug 6, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165561 ↗MalfunctionAug 6, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150546 ↗MalfunctionAug 5, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. 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: Foreign Body In Patient
MAUDE report 50144014 ↗MalfunctionAug 5, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140175 ↗MalfunctionAug 4, 2026Appropriate Device Problem Term/Code Not Available
It was reported that a broken or detached 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 50132685 ↗MalfunctionAug 4, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted into the back of upper 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 50127682 ↗MalfunctionAug 4, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. 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 50127681 ↗MalfunctionAug 3, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124414 ↗
Other Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter devices
- 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
- Stelo Glucose Biosensor (2pk) UPC STP-XN-002Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.