CLASS II ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report
Monarch Rollator Red recalled by Nova Ortho-Med
Nova Ortho-Med is recalling Monarch Rollator Red, distributed nationwide in the US. The recall was initiated on 26 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0131-2025
- FDA event ID
- 95375
- Recalling firm
- Nova Ortho-Med, Carson, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Aug 2024
- FDA classified
- 17 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 26 Aug 2024 | Recall initiated by company | |
| 17 Oct 2024 | Classified by FDA | +52 days |
| 23 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 as listed by the FDA
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
Where it was distributed
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.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Code: ITEM CODE: 4329RD SN RANGE: HT4329RDME0001 - HT4329RDMM0420 UPC: 652308012263
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95375| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Monarch Rollator Blue recalled by Nova Ortho-Med | Nova Ortho-Med | Other | Nationwide | |
| CLASS II | Monarch Rollator Purple recalled by Nova Ortho-Med | Nova Ortho-Med | Other | Nationwide |
More recalls from Nova Ortho-Med
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Monarch Rollator Purple recalled by Nova Ortho-Med | Nova Ortho-Med | Other | Nationwide |
| Device | CLASS II | Monarch Rollator Blue recalled by Nova Ortho-Med | Nova Ortho-Med | Other | Nationwide |
| Device | CLASS II | Star 8 Rolling Walker/Rollator, Items recalled by Nova Ortho-Med | Nova Ortho-Med | Potency & Assay | 38 states |
| Device | CLASS II | 4205 Journey Rolling Walker recalled by Nova Ortho-Med | Nova Ortho-Med | Other | Nationwide |
Other Wheelchairs, Beds & Lifts recalls
All 175| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Power F2 Powered Fastening System, Power F2 recalled by Ferno-Washington | Ferno-Washington | Potency & Assay | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Burgundy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Quantum Rehab Quantum 4Front 2HD recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge 2.0 (ilevel) recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |