Voyager Rollator Walkers Recalled for Wheel Separation and Fall Risk
Compass Health Brands is recalling 3,734 Voyager Rollator walkers due to cracking wheel spokes that may cause wheels to separate from the axle, potentially resulting in patient falls and injuries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a structural defect (wheel spoke cracking) that may cause patient injury. No reported injuries or hospitalizations documented in the recall notice, fitting the rubric criterion for high severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Compass Health Brands is recalling 3,734 Voyager Rollator walker units (Model RLEU10xx, in Cobalt Blue, Rose Gold, and Ice Palace variants) that were manufactured between May 2020 and April 2021. These units have been distributed nationwide.
The wheel spokes on these rollators may crack, causing the wheel to separate from the axle. This defect may result in patient injuries, including bruising and lacerations requiring stitches.
The FDA classified this as a Class II recall.
The recalled product
- 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
- Manufacturer
- Compass Health Brands (Corporate Office)
- Category
- Medical Device — Mobility Aid
- Affected units
- 3,734
Distribution
Distributed nationwide across the United States.
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