Recall Register

Food, drugs, devices › Firms

Dexcom, Inc.

FDA recalling firm · 11 enforcement events · 29 product records · 2016–2026 · CA

Dexcom, Inc. has 11 FDA enforcement events on this register (29 product records) between 2016 and 2026: 11 device; the busiest year was 2025 with 5.

36% of its events are Class I; the most common class is Class II (7). 7 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
27 May 2026Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring SystemDeviceClass II1Ongoing
14 Apr 2026Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose…DeviceClass II3Ongoing
28 Aug 2025Brand 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 SystemDeviceClass I1Ongoing
24 Jul 2025Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitoring SystemDeviceClass I5Ongoing
12 May 2025Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)DeviceClass I4Ongoing
5 May 2025Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) systemDeviceClass II1Ongoing
27 Jan 2025Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001DeviceClass II3Ongoing
3 Feb 2020Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.DeviceClass II3Terminated
19 Nov 2019Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804DeviceClass II1Terminated
12 Jul 2019Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is…DeviceClass II1Terminated
23 Feb 2016Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.DeviceClass I6Terminated

By type and class

Device11
Class II7
Class I4

Class I: 36% of this firm's events; 18% of all events on the register.

Events by year

16
17
18
19
20
21
22
23
24
25
26
Enforcement events for Dexcom, Inc. by year initiated.

Questions and answers

How many FDA recalls has Dexcom, Inc. had?

11 enforcement events (29 product records) on this register, 2016–2026: 11 device.

Are any Dexcom, Inc. recalls ongoing?

7 events are listed as ongoing in the current openFDA export.

What class are Dexcom, Inc. recalls?

7 Class II, 4 Class I. 36% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.