Stelo Glucose Biosensor (2pk)Recalls & reported problems across all models

We found 2 models of Stelo Glucose Biosensor (2pk) by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 616 adverse event reports in the FDA's MAUDE database, received between May 9, 2025 and Sep 30, 2026 — classified as 25 injuries, 591 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (369 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. 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

Most reported Stelo Glucose Biosensor (2pk) problems

Stelo Glucose Biosensor (2pk) models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Stelo Glucose Biosensor (2pk) STP-XN-002

  Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
  612 reports
• Stelo Glucose Biosensor (2pk) STP-XN-003

  Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
  4 reports

Recent Stelo Glucose Biosensor (2pk) adverse event reports

The 15 most recent reports across all models, 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 ↗

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 G7 GSS (161)4 models · 141,244 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