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Device Class II · moderate Ongoing

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

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.

Recalling firmMedline Industries, LP
ReasonThe 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.
Risk classClass II (Class II · moderate)
StatusOngoing
Report dateOct 14, 2026
InitiatedAug 14, 2026
RegionIL, United States
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Quantity835 units
Code/LotLot Numbers: 05425080001 05426040001
TypeVoluntary: Firm initiated
Recall numberZ-0087-2027

Official source

U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗

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openFDA (U.S. Food & Drug Administration) — food/drug/device enforcement · CC0 1.0 (public domain)

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