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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Nova Ortho-Med Inc: Monarch Rollators Recalled Due to Fall Hazard from Backrest Disengagement

Agency Publication Date: October 17, 2024
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Summary

Nova Ortho-Med Inc. has recalled 4,448 Monarch Rollator mobility walkers because the backrest can unexpectedly detach from its holder. This defect occurs when a user moves from a slouched to an upright seated position, causing the backrest to lift out of its unit. The recall affects three models in Blue, Purple, and Red that were sold throughout the United States and Canada. Consumers should immediately identify if they own an affected walker and contact the manufacturer for guidance as this defect can lead to serious falls.

Risk

The walker's backrest can disengage and lift out of its holder while a user is sitting, providing no support and causing the user to fall backward. This poses a significant risk of injury, especially for individuals who rely on the device for stability and mobility.

What You Should Do

  1. Check your Monarch Rollator to see if it is one of the affected models: Blue (4329BL), Purple (4329PL), or Red (4329RD).
  2. Locate the serial number (SN) on your device and compare it to the affected ranges: Blue (HT4329BLME0001 - HT4329BLPG0300), Purple (HT4329PLME0001 - HT4329PLMM0400), or Red (HT4329RDME0001 - HT4329RDMM0420).
  3. Verify the UPC code on the original packaging: Blue (652308012249), Purple (652308012256), or Red (652308012263).
  4. If your walker is part of this recall, contact your healthcare provider or Nova Ortho-Med Inc. at their Carson, California headquarters (1470 Beachey Pl, Carson, CA 90746) for further instructions and information regarding a potential remedy.
  5. For additional questions or to report a related safety incident, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: MONARCH ROLLATOR BLUE
Model / REF:
4329BL
UPC Codes:
652308012249
Lot Numbers:
SN RANGE: HT4329BLME0001 - HT4329BLPG0300
Product: MONARCH ROLLATOR PURPLE
Model / REF:
4329PL
UPC Codes:
652308012256
Lot Numbers:
SN RANGE: HT4329PLME0001 - HT4329PLMM0400
Product: MONARCH ROLLATOR RED
Model / REF:
4329RD
UPC Codes:
652308012263
Lot Numbers:
SN RANGE: HT4329RDME0001 - HT4329RDMM0420

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95375
Status: Active
Manufacturer: Nova Ortho-Med Inc
Sold By: Nova Ortho-Med Inc; Medical supply distributors
Manufactured In: United States
Units Affected: 3 products (1886; 977; 1585)
Distributed To: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.