FDA Device recall Z-0510-2022
Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blu…
- FDA Device
- Class II
- ongoing
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class II recall of Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blu… by Compass Health Brands Corporate Office, citing wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0510-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-10 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Compass Health Brands Corporate Office |
| Distribution | US |
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
Reason
Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Identifiers
| upc | 815067078066 |
|---|---|
| upc | 815067078073 |
| upc | 815067078080 |
| code_info | Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates) |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0510-2022%22
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