Dexcom Receiver — Class II medical device recall Z-0929-2020
Terminated recall by Dexcom Inc, reported 2020-02-12, distributed nationwide. It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported
| Recall number | Z-0929-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dexcom Inc, San Diego, CA, United States |
| Recall initiated | 2019-07-12 |
| Classified | 2020-01-31 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2022-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 112,415 receivers |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00386270000606, 10386270000238, 10386270000269, 10386270000276, 20386270000235, 20386270000266, 20386270000273, 30386270000232, 30386270000263, 30386270000270 |
| Model numbers | MT22719 |
Product
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
Reason for recall
It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will either reboot and operate normally or require the user to press the Select button on the receiver in order to resume normal operation. In this situation, the user is provided an audio and vibratory alert every 5 minutes. Until the select button is pressed, patients will not receive glucose values or alerts.
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-0929-2020. 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.