ACCU-CHEK Connect Diabetes Management App — Class II medical device recall Z-1369-2015
Terminated recall by Roche Diabetes Care, Inc., reported 2015-04-08. Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could
| Recall number | Z-1369-2015 |
|---|---|
| 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 | 2014-10-30 |
| Classified | 2015-04-02 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2015-06-08 |
| Countries outside the US | DE, IT, ZA |
Product
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Reason for recall
Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situation revealed that this issue may occur if the user changes the screen orientation of the phone from portrait to landscape or vise versa while looking at the Bolus Advisor or Carb
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-1369-2015. 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.