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Dexcom, Inc. FDA Recalls
18 recalls on file across devices, 10 of them Class I and 18 still open. Matched by name to DXCM.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Class IIMay 27, 2026Certain lots of Dexcom G7 sensors originally designated as s |
| Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog NumbeClass IIApr 14, 2026A software defect in which a low-priority file I/O check blo |
| Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SClass IIApr 14, 2026A software defect in which a low-priority file I/O check blo |
| Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog NumbeClass IIApr 14, 2026A software defect in which a low-priority file I/O check blo |
| Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App ModelClass IAug 28, 2025A software defect in version v1.15.0 of the G6 Android app c |
| Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SClass IJul 24, 2025The affected devices are the Dexcom G7 Continuous Glucose Mo |
| Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog NumbeClass IJul 24, 2025The affected devices are the Dexcom G7 Continuous Glucose Mo |
| Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog NumbeClass IJul 24, 2025The affected devices are the Dexcom G7 Continuous Glucose Mo |
| Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog NumbeClass IJul 24, 2025The affected devices are the Dexcom G7 Continuous Glucose Mo |
| Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog NClass IJul 24, 2025The affected devices are the Dexcom G7 Continuous Glucose Mo |
| Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0),Class IMay 12, 2025Defective foam or an assembly error may cause the receiver s |
| Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-Class IMay 12, 2025Defective foam or an assembly error may cause the receiver s |
| Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)Class IMay 12, 2025Defective foam or an assembly error may cause the receiver s |
| Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), Class IMay 12, 2025Defective foam or an assembly error may cause the receiver s |
| Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) systeClass IIMay 5, 2025A bug in the 2.7.0 version of the G7 iOS App can cause the a |
| Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001Class IIJan 27, 2025Under very rare situations, the Dexcom G6 touchscreen receiv |
| Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001Class IIJan 27, 2025Under very rare situations, the Dexcom G6 touchscreen receiv |
| Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001Class IIJan 27, 2025Under very rare situations, the Dexcom G6 touchscreen receiv |