Z-0131-2025Class II

Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product...

Name: Z-0131-2025 Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product...
Creator: Nova Ortho-Med Inc
Published: 2024-08-26
License: https://open.fda.gov/license/

Nova Ortho-Med Inc / initiated 2024-08-26 / Open, Classified / root cause: design

FDA source

Nova Ortho-Med Inc began a recall of Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID on 2024-08-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0131-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-26
Posted: 2024-10-17
Recalling firm: Nova Ortho-Med Inc
Product: Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
Product code: ITJ Walker, Mechanical
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.
Root cause tag: design
FDA 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 ([email protected]) 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: [email protected]
Quantity in commerce: 1585
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.
Product codes and lots: Lot Code: ITEM CODE: 4329RD SN RANGE: HT4329RDME0001 - HT4329RDMM0420 UPC: 652308012263

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0131-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0129-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0130-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0131-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17

Product code ITJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)