Drug & Device Safety Atlas

FDA recall record · openFDA

Dexcom, Inc.

17 FDA recalls on record (2025–2026) — 17 device. 17 still ongoing.

10
Class I (most serious)
7
Class II
0
Class III
17
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android 5
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leadi 4
Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as des 3
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing es 3
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated gl 1

Recalls

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Numbe Class I 2025-07-24 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog N Class I 2025-07-24 Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK- Class I 2025-05-12 Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), Class I 2025-05-12 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe Class I 2025-07-24 Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model Class I 2025-08-28 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe Class I 2025-07-24 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: S Class I 2025-07-24 Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1) Class I 2025-05-12 Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), Class I 2025-05-12 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe Class II 2026-04-14 Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: S Class II 2026-04-14 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Numbe Class II 2026-04-14 Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 Class II 2025-01-27 Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 Class II 2025-01-27 Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) syste Class II 2025-05-05 Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 Class II 2025-01-27

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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