Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Descriptio
Summary
The FDA issued a Class II for Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Ca by Nova Ortho-Med Inc. 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, .
Details
Source
Device Recall
External ID
Z-0130-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
Lot/Code Info: Lot Code: ITEM CODE: 4329PL SN RANGE: HT4329PLME0001 - HT4329PLMM0400 UPC: 652308012256
Quantity Affected: 977
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-26
Company
Carson, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nova Ortho-Med Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nova Ortho-Med Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nova Ortho-Med Inc have FDA actions?
Nova Ortho-Med Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0130-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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