CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report
InPen Diabetes Management App, part of the InPen System recalled
Companion Medical is recalling InPen Diabetes Management App, part of the InPen System, distributed nationwide in the US. The recall was initiated on 8 Nov 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0741-2023
- FDA event ID
- 91158
- Recalling firm
- Companion Medical, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Nov 2022
- FDA classified
- 20 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 8 Nov 2022 | Recall initiated by company | |
| 20 Dec 2022 | Classified by FDA | +42 days |
| 28 Dec 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA.
Where it was distributed
US Nationwide distribution including in the states of CA, NY, MT, OH, IN, MN, PA, CT, TX, WA, TN, SD, MI, FL, OR, NC, KY, WI, MO, WV, NV, SC, AZ, AR, MA, LA, VT, GA.
Nationwide ArkansasArizonaCaliforniaConnecticutFloridaGeorgiaIndianaKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriMontanaNorth CarolinaNevadaNew YorkOhioOregonPennsylvania
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
InPen Software App for Android, versions 5.6.1.1 and 5.6.2 with InPen System REF/UDI-DI: MMT-105ELBLNA/10862088000313, MMT-105ELGYNA/10862088000320, MMT-105ELPKNA/10862088000337, MMT-105NNBLNA/10862088000344, MMT-105NNGYNA/10862088000351, MMT-105NNPKNA/10862088000368.
Where was it sold?
US Nationwide distribution including in the states of CA, NY, MT, OH, IN, MN, PA, CT, TX, WA, TN, SD, MI, FL, OR, NC, KY, WI, MO, WV, NV, SC, AZ, AR, MA, LA, VT, GA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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