Nova Ortho-Med Inc: Device Recall
Recall #Z-0130-2025 · 08/26/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0130-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Nova Ortho-Med Inc
- Status
- Ongoing
- Date Initiated
- 08/26/2024
- Location
- Carson, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 977
Reason for Recall
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.
Product Description
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
Distribution Pattern
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.
Other Recalls by Nova Ortho-Med Inc
- Class II: Risk 08/26/2024
- Class II: Risk 08/26/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.