Medtronic MiniMed, Inc. recalls InPen App, Model/CFN Number: MMT-8061 (Android Users)
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on…
Read the official notice →- Date
- 2025-12-24
- Country
- United States
- Brand
- Medtronic MiniMed
- Product
- InPen App, Model/CFN Number: MMT-8061 (Android Users)
- Classification
- Class II
- Units
- US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic MiniMed recalls
- 2026-04-08
USMedtronic MiniMed, Inc. recalls MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - US Nationwide distribution including in the states of OR, CA, AZ,…Official notice →- 2026-04-01
- US
Medtronic MiniMed, Inc. recalls MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - 2026-02-11
- US
Medtronic MiniMed, Inc. recalls MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for…
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. National distribution including in the states of AL, AR, AZ,…Official notice → - 2025-12-03
- US
Medtronic MiniMed, Inc. recalls CareLink Clinic, REF: MMT-7350
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide Distribution: US (nationwide) including states of: TX, NC, MN, CA,…Official notice → - 2025-10-08
- US
Medtronic MiniMed, Inc. recalls Medtronic, Simplera Sensor, REF: MMT-5100JD1
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
FDA · DeviceMedtronic MiniMed, Inc.US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United…Official notice → - 2025-09-10
- US
Medtronic MiniMed, Inc. recalls InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose…
FDA · DeviceMedtronic MiniMed, Inc.International distribution to the countries of Argentina, Australia, Austria,…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-31
- US
Merck Sharp & Dohme LLC recalls Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ…
Presence of particulate matter: potential presence of metal particulates in the product.
- 2025-12-24
- US
Abbott Laboratories recalls Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series…
FDA · DeviceAbbott LaboratoriesWorldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice → - US
Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
FDA · DeviceCepheidUS: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI…Official notice → - US
Smith & Nephew, Inc. recalls BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Removal of affected lot of screws due to labeling error.
FDA · DeviceSmith & Nephew, Inc.US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN,…Official notice → - US
Myofunctional Research Company USA recalls Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3…
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
FDA · DeviceMyofunctional Research Company USAU.S. (nationwide) distribution to states of: Nationwide: AK, AR, CA, CO, FL,…Official notice → - US
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A…
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
FDA · DeviceRocket Medical PlcDomestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX; International: UAE,…Official notice →