FDA DevicesClass II

Brand 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 System

Publicado: 1 de julio de 2026ID de Retiro: Z-2574-2026Categoría: Dispositivos MédicosPaís: Estados Unidos
US
Medical DeviceFDA DevicesUSUS

Brand 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 System

Recalling Firm: Dexcom, Inc.

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Traducir AvisoTranslate notice text, hazard warnings, and descriptions into any supported language.

Motivo del Retiro / Peligro

Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.

Descripción del Producto e Identificación

Brand 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 System

Productos Afectados

Brand 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 System

Additional Source Details

FieldValue
CitySan Diego
StateCA
Event id98968
Address 16340 Sequence Dr
Address 2N/A
Code infoLot Code: UDI-DI: 00386270004109 Lot Numbers: 1725204004 and 1725069002
Postal code92121-4356
Report date20260701
Product typeDevices
Product quantityN/A
Reason for recallCertain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260527
Initial firm notificationLetter
Center classification date20260624

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pac...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Resumen

  • Empresa ResponsableDexcom, Inc.
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionDexcom does not have distribution records for this product due to its unauthorized release. However Dexcom is able to identify sensor session starts for the affected lots through the Dexcom G7 CGM App user performance data. Based on App user performance data, Lot 1725204004 has sensor session starts in the United States. Based on App user performance data, Lot 1725069002 has sensor session starts in the United States and the countries of Australia, Austria, Canada, Czech Republic, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, South Korea, Kuwait, Netherlands, Poland, Portugal, Qatar, Singapore, Spain, Switzerland, Turkey, United Arab Emirates,and the United Kingdom.
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: Dexcom, Inc. - Brand 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 System

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