FDAClass II · Medical device · Recall Z-2164-2026 · Recalled May 20, 2026
Brand Name recall — Dexcom, Inc.
Agency report date: May 20, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: Brand Name recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
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- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 18, 2026 at 6:00 PM UTC.