Nova Ortho-Med Inc: Medical Device Recall in 2020 - (Recall #: Z-0654-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 7, 2019

Date Posted: December 30, 2020

Recall Number: Z-0654-2021

Event ID: 86941

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.

Status: Ongoing

Product Quantity: 10898

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated