Accu-Chek Connect Diabetes Management App — Class II medical device recall Z-0625-2018
Terminated recall by Roche Diabetes Care, Inc., reported 2018-02-21, distributed nationwide. Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a soft
| Recall number | Z-0625-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diabetes Care, Inc., Indianapolis, IN, United States |
| Recall initiated | 2017-06-08 |
| Classified | 2018-02-15 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-07-27 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00365702700000, 00365702700017 |
| Model numbers | 07250452001, 07562462001 |
Product
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017
Reason for recall
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change. This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.
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-0625-2018. 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.