Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purp
Summary
The FDA issued a Class II for Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and by Medline Industries, LP. Reason: 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.
Details
Source
Device Recall
External ID
Z-0086-2027
Action Date
2026-10-14
Status
Ongoing
Category
device
Product Description
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/Code Info: Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001
Quantity Affected: 1824 units
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.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-14
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 220 device recalls issued in the same week, part of 502 device-related FDA actions this month.
Medline Industries, LP has 586 FDA actions in our database, including 557 recalls and 29 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 586 FDA actions in our database, including 557 recalls and 29 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0086-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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