Drugs & medicalClass II

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.

Read the official notice →
Date
2025-10-08
Country
United States
Brand
Medtronic MiniMed
Product
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Classification
Class II
Units
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2026-02-11
  2. US
    Drugs & medicalClass II

    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 →
  3. 2025-12-24
  4. US
    Drugs & medicalClass II

    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…

    FDA · DeviceMedtronic MiniMed, Inc.US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI,…Official notice →
  5. 2025-12-03
  6. US
    Drugs & medicalClass II

    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 →
  7. 2025-09-10
  8. US
    Drugs & medicalClass II

    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 →
  9. 2025-04-30
  10. US
    Drugs & medicalClass II

    Medtronic MiniMed, Inc. recalls InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

    Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove…

    FDA · DeviceMedtronic MiniMed, Inc.US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH,…Official notice →
  11. 2025-03-12
  12. US
    Drugs & medicalClass II

    Medtronic MiniMed, Inc. recalls MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)

    All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane…

    FDA · DeviceMedtronic MiniMed, Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
All 19 Medtronic MiniMed recalls →

Other drugs & medical recalls in the United States

  1. 2025-10-08
  2. US
    Drugs & medicalClass I

    Medline Industries, LP recalls Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B

    Convenience kits labeled as sterile have not gone through the sterilization process.

    FDA · DeviceMedline Industries, LPUS Distribution to States of: FL, MD, NJ, TNOfficial notice →
  3. US
    Drugs & medicalClass II

    W L Gore & Associates, Inc. recalls GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W,…

    Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to…

    FDA · DeviceW L Gore & Associates, Inc.US: OR, AL, OH, MD, VA, CA, FL, NC, OK, MA, MO, AZ, TX, IL, GA, PA, NH, HI,…Official notice →
  4. US
    Drugs & medicalClass II

    LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8)…

    The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

    FDA · DeviceLeMaitre Vascular, Inc.US Nationwide distribution in the states of CA, CT, FL, GA, IL, MA, MS, NC,…Official notice →
  5. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i…

    On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress…

    FDA · DeviceBeckman Coulter Inc.Internationally distribution to the countries of Poland, India, Dominican…Official notice →
  6. US
    Drugs & medicalClass II

    CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Radiology Solutions software version 14.2.2

    Due to software issue, radiology reports may not be fully displayed when viewing.

    FDA · DeviceCHANGE HEALTHCARE CANADA COMPANYWorldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL,…Official notice →
  7. US
    Drugs & medicalClass II

    Aesculap AG recalls AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

    Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

    FDA · DeviceAesculap AGUS distribution to Missouri. OUS International distribution to Norway,…Official notice →
See all drugs & medical recalls →