FDA Medical Device Recalls (openFDA)
Nova Ortho-Med Inc: Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
- Recall number
- Z-0130-2025
- Recalling firm
- Nova Ortho-Med Inc
- Product
- Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
- Status
- Open, Classified
- Initiated
- 2024-08-26
- Posted
- 2024-10-17
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- On 09/25/2024, the firm sent via email an "Urgent: Medical Device Correction" letter to inform customers that 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 resulting in potential fall risks. Customers are instructed to: Immediately take the following steps to correct the affected units. 1. Print the NOVA MONARCH Model 4329 Product Recall Notice and post it in your store in a visible location to customers. 2. Check your inventory for 4329 model walkers (4329BL, 4329PL and 4329RD), isolate and hold the products until you contact NOVA ORTHO-MED INC for the next steps. 3. Contact all customers who purchased a 4329 model to notify them of the potential issue. Schedule a time that they can come in for repair or if the customer prefers NOVA can send the replacement components directly to their residence. 4. If you do not track serial numbers with customer purchase or do not have the customer information, please ensure that the NOVA MONARCH Model 4329 Product Recall Notice document is posted in a customer visible location. 5. Call NOVA customer service and request the replacement component to be sent to the required location. (Part# - HCT-432915) 6. Record the serial # s of the product that have been corrected and email them to NOVA Customer Service (info@novajoy.com) so that we can have for our records. If you prefer to call, then dial 1-800-557-6682. For questions or assistance - Contact Information: Monday through Friday, 8:30 AM to 5:00 PM, Pacific time Time. "Toll free number: 1-800-557-6682 "Email: info@novajoy.com
- Quantity
- 977
- Distribution
- 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.
- Lot, serial or model codes
- Lot Code: ITEM CODE: 4329PL SN RANGE: HT4329PLME0001 - HT4329PLMM0400 UPC: 652308012256
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITJ
- Firm FEI
- 3002329391
- Firm city
- Carson
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28