BEUDAMED
    FDA Enforcement Class II Ongoing

    Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050

    Recall: Z-2273-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2273-2026
    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 size: 9 Fr REF: 90050

    Reason

    Temperature probe devices lack FDA clearance.

    Code Info

    UDI: 10884521828391, 30884521828395/ Lot: 24D1130JZX 25A1086JZX 25E1332JZX 25I1054JZX 24D1133JZX 25A1087JZX 25F0946JZX 25I1055JZX 24E1015JZX 25A1088JZX 25F0947JZX 25I1056JZX 24E1017JZX 25D0379JZX 25F0948JZX 25I1057JZX 24E1018JZX 25D0380JZX 25F0949JZX 25I1058JZX 24L0848JZX 25D0381JZX 25F0950JZX 25I1059JZX 24L0850JZX 25D1271JZX 25F0953JZX 25I1061JZX 25A1069JZX 25D1272JZX 25F0954JZX 25K1129JZX 25A1070JZX 25D1273JZX 25G1163JZX 25K1130JZX 25A1072JZX 25E1263JZX 25H0935JZX 25K1131JZX 25A1075JZX 25E1264JZX 25H0936JZX 25L0542JZX 25A1076JZX 25E1265JZX 25H0938JZX 25L0545JZX 25A1077JZX 25E1326JZX 25H0939JZX 25L0899JZX 25A1082JZX 25E1329JZX 25H0940JZX 25L0901JZX 25A1084JZX 25E1331JZX 25H0942JZX 25L0903JZX 25A1085JZX

    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

    128,900 units