Medline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
Medline is recalling 1,824 bariatric rollators because the front wheel assembly may detach, posing a risk of falls and serious injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source describes a risk of severe adverse events, including falls resulting in head trauma and bone fractures, but does not report any specific illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 1,824 units of the Bariatric Basic Steel Rollator (Product Number MDS86800XWS). The recall involves specific lot numbers: 05425090001, 05425120001, 05426010001, 05426020001, 05426030001, 05426040001, and 05426050001. These devices were distributed nationwide in the United States and in Canada.
The recall is due to a defect where the front fork stem bolt and wheel assembly may disconnect from the rollator frame tubing. If this disconnection occurs, the front wheels may become loose or detach from the rollator during use. This failure creates a risk of severe adverse events, including falls that could result in head trauma, bone fractures, or other critical injuries.
Consumers who have this product should stop using it immediately and contact Medline Industries, LP for instructions on how to proceed with the recall.
The recalled product
- Product
- 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
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Mobility Aids
- Hazard
- Affected units
- 1,824
Distribution
Distributed nationwide across the United States.
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