Recall archive / FDA device enforcement
InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELP... — FDA record Z-0741-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Companion Medical, Inc.
- Quantity
- 140
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0741-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 28, 2022
- Recall initiation date
- Nov 8, 2022
- Center classification date
- Dec 20, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.