CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

Rollator, Bariatric, Basic Steel, Burgundy recalled

Medline Industries is recalling Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal, distributed nationwide in the US. The recall was initiated on 14 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001
Quantity recalled1824 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0086-2027
FDA event ID
99807
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
14 Aug 2026
FDA classified
5 Oct 2026
Reported
14 Oct 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Foreign Material

Timeline

14 Aug 2026Recall initiated by company
5 Oct 2026Classified by FDA+52 days
14 Oct 2026Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it 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 trauma, bone fractures, or other critical injuries.

Which lots are affected?

Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99807

This product is part of a recall event; the main page for the event is Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries.

More recalls from Medline Industries

All 709

Other Wheelchairs, Beds & Lifts recalls

All 174