CLASS II ONGOING Device recall · Reported 26 Jan 2022 · FDA Enforcement Report
Voyager Rollator-intended as a mechanical walker recalled
Compass Health Brands (Corporate Office) is recalling Voyager Rollator-intended as a mechanical walker, distributed nationwide in the US. The recall was initiated on 10 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0510-2022
- FDA event ID
- 89389
- Recalling firm
- Compass Health Brands (Corporate Office), Middleburg Heights, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jan 2022
- FDA classified
- 19 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 10 Jan 2022 | Recall initiated by company | |
| 19 Jan 2022 | Classified by FDA | +9 days |
| 26 Jan 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Which lots are affected?
Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Compass Health Brands (Corporate Office)
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REX (Recovery Exercise X-Trainer) Pressure Therapy System recalled | Compass Health Brands (Corporate Office) | Other | Nationwide |
| Device | CLASS II | MediPress pneumatic compression system Full Arm recalled | Compass Health Brands (Corporate Office) | Other | 36 states |
| Device | CLASS II | MediPress pneumatic compression system Full Arm recalled | Compass Health Brands (Corporate Office) | Other | 36 states |
| Device | CLASS II | MediPress pneumatic compression system Full Leg recalled | Compass Health Brands (Corporate Office) | Other | 36 states |
| Device | CLASS II | MediPress pneumatic compression system Full Leg recalled | Compass Health Brands (Corporate Office) | Other | 36 states |
Other Wheelchairs, Beds & Lifts recalls
All 172| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Quantum Rehab Quantum 4Front 2HD recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge 2.0 (ilevel) recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |