BEUDAMED
    FDA Recall Open, Classified

    Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers

    Recall: Z-0233-2026 · Initiated September 17, 2025

    Recall

    Recall Number
    Z-0233-2026
    Event Number
    97614
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FLL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 17, 2025
    Posted
    October 23, 2025
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermometers and Welch Allyn SureTemp Plus 692 (01692-200) thermometers

    Reason

    Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.

    Action

    Beginning September 17, 2025, firm notified impacted distributors via Medical Device Recall letters. Customers were instructed to return any affected product and submit a request for replacements. Distributors were instructed to notify their end users via a provided Important Product Information Letter. For general questions regarding this action, please contact Welch Allyn technical service at 800-535-6663. Select the following sequence of options: 2 (technical support), 1(English), 1 (physical exam devices), 3 (thermometry), between the hours of 8:00 AM and 8:00 PM Eastern Time, Monday through Friday.

    Distribution

    Distribution US nationwide, Canada and Colombia.

    Quantity

    5209