Z-0086-2027 Class II Ongoing
FDA device recall Z-0086-2027 was initiated by Medline Industries, LP on Aug 14, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1824 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2026
- Initiation Date
- Aug 14, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1824 units
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
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 Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0086-2027
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026