Medline Industries, LP: Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- 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
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall initiated
- 2026-08-14
- Code info
- Lot Numbers: 05425080001 05426040001
- Product quantity
- 835 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 99807
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