High FDA (Devices)·Z-0129-2025·Announced 2024-10-23

Rolling Walker Backrest May Disengage During Position Adjustment

Nova Ortho-Med is recalling 1,886 MONARCH ROLLATOR BLUE rolling walkers due to a potential fall hazard. The backrest may disengage when users shift from a slouched to upright seated position.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall for a fall hazard on mobility equipment used by elderly and disabled individuals. No injuries or deaths have been reported; the hazard is potential rather than confirmed. This meets the High (3) severity threshold for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nova Ortho-Med Inc. is recalling the MONARCH ROLLATOR BLUE (Model 4329BL), a rolling walker used for mobility assistance. This Class II medical device recall affects 1,886 units distributed nationwide throughout the United States and Canada. Affected units have serial numbers HT4329BLME0001 through HT4329BLPG0300.

The hazard occurs when users transition from a slouched seated position to an upright seated position. During this movement, the backrest may lift out of its holder and disengage from the unit, creating a potential fall risk.

Individuals using a rolling walker depend on the structural integrity and proper function of all components, including backrest support. A disengaged backrest during position adjustment could result in loss of support and a fall.

The recalled product

Product: Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
Manufacturer: Nova Ortho-Med Inc
Category: Medical Device — Mobility Aid / Rolling Walker
Hazard: fall-hazard
backrest-disengagement
Affected units: 1,886

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Nova Ortho-Med Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Nova Ortho-Med Inc

See all →

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Rolling Walker Backrest May Disengage During Position Changes Creating Fall Risk
FDA (Devices) · 2024-10-23
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Nova Ortho-Med Rollator Backrest May Disengage During Position Adjustment
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Nova Ortho-Med Recalls Star 8 Rolling Walkers Due to Fork Detachment Risk
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Nova Medical Recalls Journey Rolling Walkers Due to Loose Screws
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Same hazard · fall hazard