Severity
Moderate
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Reported: June 11, 2025 Initiated: May 5, 2025 #Z-1906-2025 61,355 users units
Dexcom, Inc. issued this FDA Devices recall on June 11, 2025. Classified as Moderate severity (Class II). Approximately 61,355 users units are affected. The recall was issued because: 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 g…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1906-2025) was formally reported on June 11, 2025, with the manufacturer initiating the action on May 5, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Dexcom, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records indicate 61,355 users units are affected.
The documented reason for this recall is: 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 glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are no… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
61,355 users
Related Recalls
6
6 from same agency
Product Description
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Reason for Recall
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 glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
Details
- Recalling Firm
- Dexcom, Inc.
- Units Affected
- 61,355 users
- Distribution
- Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), United Kingdom (GB), Hong Kong (HK), Ireland (IE), Israel (IL), Iceland (IS), Italy (IT), Jordan (JO), Korea, Repulic (KR), Kuwait (KW), Lebanon (LB), Lithuania (LT), Luxemburg (LU), Malta (MT), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Poland (PL), Portugal (PT), Qatar (QA), Saudi Arabia (SA), Sweden (SE), Slovenia (SI), Slovakia (SK), Turkey (TR) and South Africa (ZA).
- Location
- San Diego, CA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1906-2025 |
| Date reported | June 11, 2025 |
| Date initiated | May 5, 2025 |
| Recalling firm | Dexcom, Inc. |
| Units affected | 61,355 users |
| Distribution | Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK),… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system. Recalled by Dexcom, Inc.. Units affected: 61,355 users.
Why was this product recalled? ▼
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 glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2025. Severity: Moderate. Recall number: Z-1906-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), United Kingdom (GB), Hong Kong (HK), Ireland (IE), Israel (IL), Iceland (IS), Italy (IT), Jordan (JO), Korea, Repulic (KR), Kuwait (KW), Lebanon (LB), Lithuania (LT), Luxemburg (LU), Malta (MT), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Poland (PL), Portugal (PT), Qatar (QA), Saudi Arabia (SA), Sweden (SE), Slovenia (SI), Slovakia (SK), Turkey (TR) and South Africa (ZA)..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1906-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).