Z-0654-2021Class II

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

Name: Z-0654-2021 Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Creator: Nova Ortho-Med Inc
Published: 2019-10-07
License: https://open.fda.gov/license/

Nova Ortho-Med Inc / initiated 2019-10-07 / Open, Classified / root cause: design

FDA source

Nova Ortho-Med Inc began a recall of Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red) on 2019-10-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0654-2021
Classification: Class II
Status: Open, Classified
Initiated: 2019-10-07
Posted: 2020-12-21
Recalling firm: Nova Ortho-Med Inc
Product: Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Product code: ITJ Walker, Mechanical
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/07/2019, Product Correction and Product Safety Recall notices were emailed to customers. Customers were asked to replace the front leg assemblies as follows: a. Depress the push buttons on the original legs and remove them from the frame. b. Insert the improved replacement assemblies issued by NOVA into the unit and discard the original legs. In addition, customers were asked to do the following: 1. Check your inventory for affected walkers and fix. 2. Contact all customers who purchased affected walkers notify them of the potential issue. Schedule a time that they can come in for repair or if the customer prefers the recalling firm can send the wheel assemblies directly to their residence. Have them inspect their walker immediately to identify if either of the front forks have unscrewed from the leg. If so, please instruct them to not use the walker until the leg assemblies can be replaced with the new parts. 3. Call the recalling firm to request the wheel assembly set to be sent to the required location. 4. Record the serial #'s of the product that have been corrected and email them to Customer Service ([email protected]) so that we can have for our records. If you prefer to call, then dial 1-800-557-6682 x8129. Email: [email protected]
Quantity in commerce: 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
Product codes and lots: Serial # range: HF-4258BKHA0001 to HF4258RDHK0352 (Purchased before April 4th,2019)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0654-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0654-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-30	2020-12-21

Product code ITJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)