CLASS II ONGOING Device recall · Reported 30 Dec 2020 · FDA Enforcement Report
Star 8 Rolling Walker/Rollator, Items recalled by Nova Ortho-Med
Nova Ortho-Med is recalling Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue), distributed in 38 states. The recall was initiated on 7 Oct 2019 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-0654-2021
- FDA event ID
- 86941
- Recalling firm
- Nova Ortho-Med, Carson, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Oct 2019
- FDA classified
- 21 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 7 Oct 2019 | Recall initiated by company | |
| 21 Dec 2020 | Classified by FDA | +441 days |
| 30 Dec 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Where it was distributed
U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, WY O.U.S.: Taiwan
AlaskaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.
Which lots are affected?
Serial # range: HF-4258BKHA0001 to HF4258RDHK0352 (Purchased before April 4th,2019)
Where was it sold?
U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, WY O.U.S.: Taiwan
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.
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 | Monarch Rollator Red recalled by Nova Ortho-Med | Nova Ortho-Med | Other | Nationwide |
| 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 |