Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product… — Class II medical device recall Z-2164-2026
Ongoing recall by Dexcom, Inc., reported 2026-05-20, distributed nationwide. A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for pro
| Recall number | Z-2164-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dexcom, Inc., San Diego, CA, United States |
| Recall initiated | 2026-04-14 |
| Classified | 2026-05-11 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, CA, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, HR, IE, IL, IS, IT, JO, JP, KR, KW, LT, LU, LV, MT, MY, NL, NO, NZ, OM, PL, PT, QA, RO, SA, SE, SG, SI, SK, TR, ZA |
| Quantity | 58,582 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00386270005168 |
| Lot numbers | SW13355 |
| Model numbers | SW13355 |
Product
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
Reason for recall
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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2164-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.