Z-0204-2015Class II

Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down...

Name: Z-0204-2015 Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down...
Creator: Roscoe Medical Inc
Published: 2014-10-01
License: https://open.fda.gov/license/

Compass Health Brands (Distribution Center) / initiated 2014-10-01 / Terminated / root cause: design

FDA source

Roscoe Medical Inc began a recall of Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded... on 2014-10-01. FDA classified it as Class II and gives the reason as "The caster may separate completely from the device frame causing injury to user". 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-0204-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-01
Posted: 2014-11-12
Terminated: 2017-02-22
Recalling firm: Compass Health Brands (Distribution Center)
Product: Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)
Product code: ITJ Walker, Mechanical
Reason for recall: The caster may separate completely from the device frame causing injury to user.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Roscoe Medical, issued a "URGENT RECALL NOTICE-Timely Response Required" Quarantine Communication to customers between 09/08/2014 and 09/10/2014. The notice identified affected products as 30194, serial number range MH140407092MH140407291, the problem and actions to be taken. The customers were instructed NOT to use this product and to destroy any affected product that may be in their inventory/control; immediately complete and return the attached Recall Response Form/Certificate of Destruction to Roscoe Medical- "Transport Rollator Recall" within 15 days of receipt of the recall notification via fax to (440) 572-4261 or email: [email protected], even if you do not have any affected product; and notify your customers immediately of this product recall. Should you have any questions, contact Roscoe Medical Customer Support at (800) 376-7263 Monday-Friday 8:00 am EST - 5:00 pm EST.
Quantity in commerce: 831 units
Distribution: Nationwide Distribution: US including states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA< MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI,and WY.
Product codes and lots: 30194, Roscoe Transport Rollator, Blue 30192, Roscoe Transport Rollator, Burgundy MH140401502-MH140401890 MH140500217-MH140500466 MH140406602-MH140406891 MH140407092-MH140407291

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0204-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0204-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-12

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)