Nova Ortho-Med Inc recalls Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

Recall date

October 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0654-2021

FDA classification

Class II

Brand / firm

Nova Ortho-Med Inc

Sold / 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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)