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FDA Medical Device Recalls (openFDA)

Silver Star Brands: 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.

Recall number
Z-0216-2015
Recalling firm
Silver Star Brands
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.
Status
Terminated
Initiated
2014-10-10
Posted
2014-11-14
Terminated
2019-05-08
Reason
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
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
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.
Lot, serial or model codes
SKU 348709 404, SKU348709 605
510(k) numbers
not on file
PMA numbers
not on file
Product code
IOR
Firm FEI
2121195
Firm city
Oshkosh
Firm state
WI
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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