BEUDAMED
    FDA Enforcement Class II Ongoing

    Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

    Recall: Z-1689-2026 · Reported April 8, 2026

    Enforcement

    Recall Number
    Z-1689-2026
    Event ID
    98419
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ultradent Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    April 8, 2026
    Initiation Date
    January 28, 2026
    Classification Date
    March 27, 2026
    Address
    505 W 10200 S, South Jordan, UT, 84095-3800, United States

    Description

    Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

    Reason

    Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.

    Code Info

    UDI-DI: E29270111. Lot: 529983. Expiration: 2031-09-02

    Distribution

    US: MA, WI, ME, AL, NY, MN, CA, KY, IL, WY, WA, OH, PR, CT, OR, NJ, MI, NC, HI, PA, NE, TX, UT, NV, LA, VA, MO, FL, AZ, WV, IA.

    Quantity

    2508