Voyager Rollator-intended as a mechanical walker Model Number:… — Class II medical device recall Z-0510-2022
Ongoing recall by Compass Health Brands (Corporate Office), reported 2022-01-26, distributed nationwide. Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including br
| Recall number | Z-0510-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Compass Health Brands (Corporate Office), Middleburg Heights, OH, United States |
| Recall initiated | 2022-01-10 |
| Classified | 2022-01-19 |
| Reported by FDA | 2022-01-26 |
| Distributed | Nationwide (US) |
| Quantity | 3,734 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00815067078066, 00815067078073, 00815067078080 |
| Serial numbers | RM2005000001-RM21004005000 |
| Model numbers | RLEU10XX |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0510-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.