Z-0510-2022Class II

Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT)...

Name: Z-0510-2022 Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT)...
Creator: Compass Health Brands (Corporate Office)
Published: 2022-01-10
License: https://open.fda.gov/license/

Compass Health Brands (Corporate Office) / initiated 2022-01-10 / Open, Classified / root cause: design

FDA source

Compass Health Brands (Corporate Office) began a recall of Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066... on 2022-01-10. FDA classified it as Class II and gives the reason as "Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches". 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-0510-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-10
Posted: 2022-01-19
Recalling firm: Compass Health Brands (Corporate Office)
Product: Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080
Product code: ITJ Walker, Mechanical
Reason for recall: Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Root cause tag: design
FDA root cause: Device Design
Action: Compass Health issued Urgent Medical Device recall letter dated January 2022 on 1/11/22 issued to Distributors and Customers via email or hard copy letter. Firm posted recall to their website: https://compasshealthbrands.com/product-recall . Letter states reason for recall, health risk and action to take: Users: Users should stop using the subject products and contact Compass Health Brands. REQUIRED ACTION: 1. The Voyager Rollator casters and axles require replacement. 2. Contact Compass Health Brands at (800) 947 1728 to order replacement kits, P/N Voyager Kit. This kit contains all the parts necessary to complete replacement of the Voyager Rollator casters and axles. 3. A Voyager Caster Installment Guide will be sent as part of the Field Action Kit P/N Voyager Kit and are posted on the Compass Health Brands website. No special certification is required. 4. Complete and return the attached Consumer Field Correction Response Form to Compass Health Brands within fifteen (15) days of receipt of this field correction notification confirming your acknowledgement. Send completed form to Compass Health Brands via email at [email protected]. Complete and return this form even if you do not have affected product on hand. 5. Field correction repairs must be completed on affected units before further use of the unit. Distributors: The manufacturer has changed the wheel spoke design to increase the spoke thickness and strength. The manufacturer will supply replacement wheels with the improvement. The improved wheels will be made available to users to replace the existing wheels on the product. 1. Ensure all affected personnel are fully informed of this notice. 2. Forward this notice to your Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians. 3. The Voyager Rollator casters and axles require replacement. 4. Dealers/distributors or end users should contact Compass Health Brands at (800) 947-1728 and to order replacem
Quantity in commerce: 3734 units
Distribution: Nationwide
Product codes and lots: Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0510-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0510-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-26	2022-01-19

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)