Z-0216-2015Class II

Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling...

Name: Z-0216-2015 Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling...
Creator: Silver Star Brands
Published: 2014-10-10
License: https://open.fda.gov/license/

Silver Star Brands Inc / initiated 2014-10-10 / Terminated / root cause: design

FDA source

Silver Star Brands began a recall of Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to... on 2014-10-10. FDA classified it as Class II and gives the reason as "Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in damaged wheels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0216-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-10
Posted: 2014-11-14
Terminated: 2019-05-08
Recalling firm: Silver Star Brands Inc
Product: Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.
Product code: IOR Wheelchair, Mechanical
Reason for recall: Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in damaged wheels..
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent on 10/10/2014 an Easy Comforts "Urgent: Rollator Recall" letter dated October 10, 2014. The letter described the problem and the product involved in the recall. Advised consignees to stop using the product immediately. The consignees can contact the Product specialist at Easy Comforts at 1-888-327-2390 Monday though Friday from 7:30 am to 3:30 pm central time.
Quantity in commerce: 129
Distribution: Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, LA, MD, MI, MO, MT, NE, NV,NH, NM, NY, NC, OH,OK, and PA.
Product codes and lots: SKU 348709 404, SKU348709 605

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0216-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0216-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-14

Product code IOR

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)