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Ongoing FDAEvent 99807 (10 days ago)

Medline Bariatric Steel Rollators

The rollator's front fork stem bolt/wheel assembly may disconnect, causing the front wheels to detach and risk severe falls.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Medline Industries, LP recalled its Rollator Bariatric Basic Steel rollators, including the Blue model (Product Number MDS86800XWBS) and the Burgundy model (Product Number MDS86800XWS), because the front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing.

If this occurs, the front wheels may become loose or detach during use, posing a risk of severe adverse events, including falls that could result in head trauma, bone fractures, or other critical injuries. The recall began on August 14, 2026, and was added to the FDA's Enforcement Report on October 5, 2026.

Summary by Recall Canary from the FDA notice.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

2 products

Affected if its lot code is listed.

  1. 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

    Lot
    • 05425080001
    • 05426040001
  2. 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

    Lot
    • 05425090001
    • 05425120001
    • 05426010001
    • 05426020001
    • 05426030001
    • 05426040001
    • 05426050001

Details

Company began the recall
Event ID
99807
Company
Medline Industries, LP
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

All recalls from Medline Industries, LP

Summary by Recall Canary, written with AI · summary updated Oct 6, 2026 · primary source: U.S. Food and Drug Administration