Medline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
Medline is recalling 835 bariatric rollators because the front wheel assembly may disconnect from the frame, posing a risk of falls and severe injuries.
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 835 units of the Bariatric, Basic Steel, Blue rollator (Product Number MDS86800XWBS). The recall involves lot numbers 05425080001 and 05426040001. These devices were distributed nationwide in the United States and in Canada.
The recall was initiated because 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. The source states that this failure creates a risk of severe adverse events, including falls resulting in head trauma, bone fractures, or other critical injuries.
The source does not report any specific illnesses, injuries, or deaths associated with this recall. Consumers who possess these specific rollators should stop using them immediately and contact Medline Industries, LP for further instructions on the recall process.
The recalled product
- 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
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Mobility Aids
- Affected units
- 835
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 05425080001 05426040001
Distribution
Distributed nationwide across the United States.
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