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FDAFDA · Food and drugs·Recall number Z-0129-2025

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

Published October 23, 2024 · Recall initiated: August 26, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Nova Ortho-Med Inc
Distributor
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.
Lot
Lot Code: ITEM CODE: 4329BL SN RANGE: HT4329BLME0001 - HT4329BLPG0300 UPC: 652308012249
Risk classification
Class II
Area (FDA)
device
Country
United States

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