FDA-Device2026-10-14Class IIPROCESSING DEFECT

Medline bariatric rollator recalled for front wheel detachment risk

OTHERNationwide distributionMedical devices

What this means

The front wheels on certain Medline bariatric rollators may become loose or detach during use because the front fork stem bolt can disconnect from the frame. If the front wheels detach while someone is using the rollator, they could fall and suffer serious injuries such as head trauma or broken bones.

  • Stop using the rollator immediately if you own model MDS86800XWS (burgundy, basic steel bariatric rollator).
  • Check the lot number on your rollator against the affected list: 05425090001, 05425120001, 05426010001, 05426020001, 05426030001, 05426040001, or 05426050001.
  • Contact Medline Industries for a replacement or repair.
  • Inspect the front wheel assembly and frame connection for any cracks, corrosion, or loose bolts before each use.
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The agency's original wording
Hazard

The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head trauma, bone fractures, or other critical injuries.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
1824 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWS

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0086-2027

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