Nova Ortho-Med Rollator Backrest May Disengage During Position Adjustment
Nova Ortho-Med is recalling the MONARCH ROLLATOR PURPLE due to a fall hazard: the backrest may disengage when users shift from a slouched to upright seated position.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (fall hazard for mobility aid users) where no illnesses or injuries have been reported. The source text describes only a 'potential risk' without documented injuries, which per the rubric places it at score 3 (High).
Plain-English summary
Nova Ortho-Med Inc. is recalling the MONARCH ROLLATOR PURPLE (Model 4329PL), a rolling walker used as a mobility aid. Approximately 977 units are affected by this recall.
The backrest on the affected rollators can lift out of its holder and disengage from the unit when a user transitions from a slouched to an upright seated position. This disengagement poses a fall hazard to users.
The affected rollators were distributed nationwide across the United States and Canada.
Consumers who own this product should contact Nova Ortho-Med Inc. for instructions regarding next steps.
The recalled product
- Product
- Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
- Manufacturer
- Nova Ortho-Med Inc
- Category
- Medical Device — Mobility Aid
- Affected units
- 977
Distribution
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 →Related recalls
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