FDAClass IIOctober 23, 2024

Brand Name: Nova Ortho-med Inc. Product Name: Monarch recall

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

Why was Brand Name: Nova Ortho-med Inc. Product Name: Monarch recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: ITEM CODE: 4329PL SN RANGE: HT4329PLME0001 - HT4329PLMM0400 UPC: 652308012256

Product
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
Recalling firm
Nova Ortho-Med Inc
Quantity
977
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.
Recall date
October 23, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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