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Class IIMedical device recallOngoing

Rollator, Bariatric recall

Recalled by Medline Industries, LP · Part of Medline Inc. of Northfield, IL · FDA report 10/14/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class
Class II
Moderate
Status
Ongoing
Recall started
08/14/2026
Distribution
Nationwide

Reason for recall

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.

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

Product
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 and code info
Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001
Quantity
1824 units
Recall number
Z-0086-2027
Event ID
99807
Initiated by
Voluntary: Firm initiated

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

  • Nationwide

Recall timeline

  1. 08/14/2026Firm started the recall
  2. 10/05/2026FDA classified it as Class II
  3. 10/14/2026Published in the FDA enforcement report

All products in this recall

2 products under event 99807

More recalls from Medline Industries

Frequently asked questions

Why was Rollator, Bariatric recalled?
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...
What does Class II mean?
Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?
Worldwide distribution - US Nationwide and the country of Canada.
Is this recall still active?
The FDA lists the recall as ongoing. The recall is still in progress.

Subsidiary of Medline Inc. (MDLN) · financials and records from other agencies

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 10/14/2026 · Do not rely on openFDA to make decisions regarding medical care