BEUDAMED
    FDA Enforcement Class II Ongoing

    Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044

    Recall: Z-2272-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2272-2026
    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 General Purpose Temperature Probe REF: 90044

    Reason

    Temperature probe devices lack FDA clearance.

    Code Info

    UDI: 30884521828388/ Lot: 25F0945JZX 25H0949JZX, 25I1065JZX, 25I1066JZX

    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

    1775 units