BEUDAMED
    FDA Enforcement Class II Ongoing

    Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042

    Recall: Z-2271-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2271-2026
    Event ID
    98859
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 10, 2026
    Initiation Date
    April 23, 2026
    Classification Date
    May 29, 2026
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214, United States

    Description

    Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042

    Reason

    Temperature probe devices lack FDA clearance.

    Code Info

    UDI: 30884521820900/ Lot: 25D1267JZX 25E1322JZX, 25E1324JZX, 25H0920JZX,

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.

    Quantity

    23,000 units