High FDA (Devices)·Z-0654-2021·Announced 2020-12-30

Nova Ortho-Med Recalls Star 8 Rolling Walkers Due to Fork Detachment Risk

Nova Ortho-Med is recalling Star 8 Rolling Walkers because the front fork may unscrew from the leg, creating instability and a risk of the fork falling off.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a mobility aid with a structural defect that could cause instability and injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nova Ortho-Med Inc is recalling approximately 10,898 units of the Star 8 Rolling Walker/Rollator (Item 4258) in various colors. The recall covers units with serial numbers ranging from HF-4258BKHA0001 to HF4258RDHK0352, which were purchased before April 4, 2019.

The recall is due to a defect where the front fork has the potential to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability. If this condition is not detected by the user, the front fork may fall off the walker.

The affected products were distributed in the United States (including 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) and in Taiwan. Consumers should stop using the affected walkers and contact the recalling firm for instructions.

The recalled product

Product: Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Manufacturer: Nova Ortho-Med Inc
Category: Medical Device — Mobility Aids
Hazard: structural-defect
fall-risk
Affected units: 10,898

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Serial # range: HF-4258BKHA0001 to HF4258RDHK0352 (Purchased before April 4th
2019)

Distribution

Distributed in 38 states:

Same manufacturer · Nova Ortho-Med Inc

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Same hazard · structural defect