Rolling Walker Backrest May Disengage During Position Changes Creating Fall Risk
Nova Ortho-Med is recalling 1,585 MONARCH ROLLATOR RED units because the backrest may disengage from its holder when users adjust from a slouched to upright position, creating a fall hazard.
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: FDA Class II medical device recall with a specific, identified hazard (backrest disengagement) that poses a fall risk. No injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High (3) score.
Plain-English summary
Nova Ortho-Med Inc is recalling the MONARCH ROLLATOR RED (Model 4329RD), a rolling walker used as a mobility aid, due to a fall hazard. Approximately 1,585 units have been distributed.
The manufacturer identified a potential risk where the backrest may lift out of its holder and disengage from the unit when a user transitions from a slouched to upright seated position. This disengagement can create a fall hazard.
The recalled product was distributed nationwide throughout the United States and Canada, including all 50 states and U.S. territories. Affected units carry serial numbers ranging from HT4329RDME0001 to HT4329RDMM0420.
Consumers should inspect their walker for any loosening or instability of the backrest and contact Nova Ortho-Med Inc for repair or replacement options. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
- Manufacturer
- Nova Ortho-Med Inc
- Category
- Medical Device — Mobility Aid
- Hazard
- fall-risk
- backrest-disengagement
Distribution
Distributed nationwide across the United States.
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