# FDA recall Z-0654-2021

> **Nova Ortho-Med Inc** · Class II · device recall initiated 2019-10-07.

## 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.

## 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

## Key facts

- **Recall number:** Z-0654-2021
- **Recalling firm:** Nova Ortho-Med Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-07
- **Report date:** 2020-12-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carson, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0654-2021

## Citation

> AI Analytics. FDA recall Z-0654-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0654-2021. Source: US FDA. Licensed CC0.

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