InPen Diabetes Management App — Class II medical device recall Z-0741-2023
Ongoing recall by Companion Medical, Inc., reported 2022-12-28, distributed nationwide. Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in
| Recall number | Z-0741-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Companion Medical, Inc., San Diego, CA, United States |
| Recall initiated | 2022-11-08 |
| Classified | 2022-12-20 |
| Reported by FDA | 2022-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 140 |
| UPC / GTIN / UDI-DI | 10862088000313, 10862088000320, 10862088000337, 10862088000344, 10862088000351, 10862088000368 |
| Model numbers | MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA |
Product
InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
Reason for recall
Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating the app has stopped or isn't responding. After the crash, a present dose reminder is not displayed, which may lead to delayed insulin therapy and potentially resulting in hyperglycemia.
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-0741-2023. 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.