Device recall
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
- Recall number
- Z-0086-2027
- Event id
- 99807
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Oct 14, 2026
- Posted
- Oct 5, 2026
- Initiated
- Aug 14, 2026
- Center classification date
- Oct 5, 2026
- Product code
- ITJ
- Device type
- Walker, Mechanical
- 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 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.
- Root cause
- Process control
- Quantity
- 1824 units
- Code info
- Lot Numbers: 05425090001 05425120001 05426010001 05426020001 05426030001 05426040001 05426050001
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States