Star 8 Rolling Walker/Rollator — Class II medical device recall Z-0654-2021
Ongoing recall by Nova Ortho-Med Inc, reported 2020-12-30, distributed in AK, AR, AZ, CA, CO, CT, FL, GA…. Walkers within the identified serial range have the potential for the front fork to unscrew itself from the le
| Recall number | Z-0654-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nova Ortho-Med Inc, Carson, CA, United States |
| Recall initiated | 2019-10-07 |
| Classified | 2020-12-21 |
| Reported by FDA | 2020-12-30 |
| Distributed | 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 |
| Countries outside the US | TW |
| Quantity | 10,898 |
| Model numbers | 4258 |
Product
Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0654-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.