Karman Healthcare Recalls Karma Flexx Wheelchairs Due to Incorrect Hardware
Karman Healthcare is recalling 35 Karma Flexx manual wheelchairs because incorrect size screws and hardware were installed on the front caster fork brackets.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a mobility device (incorrect hardware on caster brackets) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Karman Healthcare, Inc. is recalling 35 units of the Karma Flexx Manual Wheelchair. The recall is due to incorrect size screws and corresponding hardware being installed on the front caster fork brackets.
The affected wheelchairs were distributed in the United States to Washington, California, New York, and Texas. The specific items involved are identified by Item # 935-0245H6, 935-0246H6, and 935-0247H6, with serial numbers ranging from TM14-A03982 to TM14-A04017.
Consumers who own these specific wheelchairs should contact Karman Healthcare for instructions on how to resolve the issue. The source text does not provide specific contact details or a deadline for the recall.
The recalled product
- Product
- Karma Flexx Wheelchair Manual Wheelchair.
- Manufacturer
- Karman Healthcare Inc
- Category
- Medical Device — Mobility Aids
- Affected units
- 35
Distribution
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