medical HIGH RISK Updated 2025-11-05

Dexcom, Inc. recalls Brand Name: Dexcom G6 Continuous Glucose Monitoring System

See all recalls from Dexcom, Inc. →

Recalled Product

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

Issued by

FDA

Distribution: This product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details.
Lot/Code Info: Lot Code: UDI: SW11678 - 00386270000811

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Brand Name: Dexcom G6 →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Philips North America Llc recalls Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232

2026-07-01 · Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System, Large, Augment, Off-

2026-07-01 · Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

SURGIFY MEDICAL OY recalls Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG

2026-07-01 · Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

SURGIFY MEDICAL OY recalls Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.

2026-07-01 · Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).