Class II — Nova Ortho-Med Inc
| Recalling firm | NOVA ORTHO-MED, INC. |
|---|---|
| Registered facility | NOVA ORTHO-MED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red) |
| Quantity | 10898 |
| Distribution | 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 |
| Initiated | 2019-10-07 |
| Classified | 2020-12-21 |
| Recall number | Z-0654-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nova Ortho-Med Inc (Z-0654-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86941/
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