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Use caution Medical device recall · FDA · Published January 10, 2022

Compass Health Voyager Rollator Recall: Wheel Spoke Crack Risk

Compass Health recalls Voyager Rollators (RLEU10BL, RLEU10PK, RLEU10WT) due to potential wheel spoke cracks causing injuries. Affected units manufactured May 2020-April 2021.

🇺🇸 FDA recall #Z-0510-2022Medical deviceCompass Health ›
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Recalling firmCompass Health Brands (Corporate Office)6753 Engle Rd · Middleburg Heights, OH 44130-7934
✎ GovInfoNow plain-language explainer

Compass Health is recalling Voyager Rollators (model RLEU10xx) because wheel spokes can crack, potentially causing injuries like lacerations requiring stitches. This risk affects users who may have purchased these walkers between May 2020 and April 2021. Read more at govinfonow.com/recall/61287-compass-health-voyager-rollator-recall-wheel-spoke-crack-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61287-compass-health-voyager-rollator-recall-wheel-spoke-crack-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0510-2022

Cite this page

“Compass Health Voyager Rollator Recall: Wheel Spoke Crack Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61287-compass-health-voyager-rollator-recall-wheel-spoke-crack-risk. Based on FDA recall #Z-0510-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0510-2022%22&limit=1).

Compass Health Brands voluntarily recalled Voyager Rollators on Jan. 10, 2022, after the FDA announced the devices pose a hazard of wheel separation that may cause patient injuries including bruising and lacerations. The Food and Drug Administration issued the Class II recall for units distributed nationwide.

How to tell if you have it

  • Brand: Compass Health
  • Product: Voyager Rollator-intended as a mechanical walker
  • Model Numbers: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT)
  • UPCs: 815067078066, 815067078073, 815067078080
  • Lot Codes: RM2005000001-RM21004005000
  • Manufacture Dates: May 2020 through April 2021
  • Units Affected: 3734

The hazard

The wheel spoke may crack, causing the wheel to separate from the axle. This failure may result in patient injuries, including bruising and lacerations requiring stitches.

Context

GovInfoNow's records show Compass Health Brands has issued three other recalls since June 18, 2018, including a March 7, 2023 recall of the REX Pressure Therapy System for potential manual error misleading DVT use and an April 8, 2019 recall of the MediPress Full Leg Compression System for missing FDA clearance. Other recent recalls of similar products include Medline Bariatric Rollator Recall (Aug. 14, 2026) and Stryker XCEL Bladeless Trocar W/Stability Sleeve recalls (Aug. 19, 2026).

How to tell if you have this one

Check for model numbers RLEU10BL (Cobalt Blue), RLEU10PK (Rose Gold), or RLEU10WT (Ice Palace) on the rollator. Units manufactured from May 2020 through April 2021 are affected.

  • Brand
    Compass Health
  • Product
    Voyager Rollator
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Model Number

    Look for model numbers RLEU10BL, RLEU10PK, or RLEU10WT on the rollator.

  2. Contact Manufacturer

    Reach out to Compass Health for assistance with the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 16 days after the firm started it.

1. Firm started the recall: Jan 10, 202212. FDA classified it Class II: Jan 19, 202223. Published in FDA’s Enforcement Report: Jan 26, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0510-2022 (January 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0510-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA