FDA-Device2026-10-14Class IIPROCESSING DEFECT

Medline bariatric rollator recalled for front wheel detachment risk causing fall hazard

OTHERNationwide distributionMedical devices

What this means

The front wheel assembly on certain Medline bariatric rollators (model MDS86800XWBS) may disconnect from the frame. If this happens during use, the front wheels can become loose or detach completely, which could cause the user to fall.

  • If you own this rollator, stop using it until you contact Medline for inspection or repair.
  • Check the product number MDS86800XWBS and lot numbers 05425080001 or 05426040001 on your device.
  • Contact Medline Industries for guidance on whether your unit is affected and what remedy is available.
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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
835 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0087-2027

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