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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Compass Health Brands (Corporate Office)
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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 Codes/Lot Numbers:
Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0510-2022
Related Recalls
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
Compass Health Brands (Corporate Office)
Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Compass Health Brands (Corporate Office)
Product design change did not receive proper premarket clearance and lacks a 510 (k)
MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
Compass Health Brands (Corporate Office)
Product design change did not receive proper premarket clearance and lacks a 510 (k)