BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2273-2026 · Initiated April 23, 2026

    Recall

    Recall Number
    Z-2273-2026
    Event Number
    98859
    Firm
    Covidien LLC
    FEI Number
    2936999
    Product Code
    BZT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 23, 2026
    Posted
    May 29, 2026
    Address
    6135 Gunbarrel Ave, Boulder, CO, 80301-3214

    Description

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

    Reason

    Temperature probe devices lack FDA clearance.

    Action

    On April 23, 2026 Covidien (subsidiary of Medtronic) issued a Urgent Medical Device Recall Notification to affected consignees via USPS. Covidien ask consignees to take the following actions: 1. Quarantine all unused product from the affected lots. 2. Return all unused product(s) from the affected lots in your inventory to Medtronic as described in the Customer Confirmation Form. 3. Share this notice with all relevant personnel within your organization, and with any organization to which the potentially affected product from the specified lots has been transferred or distributed. 4. Please complete and return the enclosed Customer Confirmation Form to [email protected] even if you do not have unused inventory.

    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