BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID

    Recall: Z-0131-2025 · Reported October 23, 2024

    Enforcement

    Recall Number
    Z-0131-2025
    Event ID
    95375
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nova Ortho-Med Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2024
    Initiation Date
    August 26, 2024
    Classification Date
    October 17, 2024
    Address
    1470 Beachey Pl, Carson, CA, 90746-4002, United States

    Description

    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID

    Reason

    Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit.

    Code Info

    Lot Code: ITEM CODE: 4329RD SN RANGE: HT4329RDME0001 - HT4329RDMM0420 UPC: 652308012263

    Distribution

    Worldwide - U.S. Nationwide distribution including in the states of AK, AL AZ, CA, CO, CT, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI and WY. The country of Canada.

    Quantity

    1585