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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

Class II
Recalling firm
Medline Industries, LP
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.
Affected products (lot / model / serial)
Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001
Units affected
1824 units
Distribution pattern
Worldwide distribution - US Nationwide and the country of Canada.
Firm location
Northfield, IL, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-0086-2027
Recall initiated
August 14, 2026
FDA classification date
October 5, 2026
FDA report date
October 14, 2026
FDA event ID
99807
Last updated on HTM Vibe
October 21, 2026
View on openFDA