Nova Ortho-Med Inc: Device Recall

Recall #Z-0129-2025 · 08/26/2024

Class II: Risk

Recall Details

Recall Number
Z-0129-2025
Classification
Class II
Product Type
Device
Recalling Firm
Nova Ortho-Med Inc
Status
Ongoing
Date Initiated
08/26/2024
Location
Carson, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1886

Reason for Recall

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.

Product Description

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

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.