Standing Company Recalls Superstand Wheelchairs Due to Flex Shaft Fracture Risk
The Standing Company is recalling approximately 119 Superstand stand-up wheelchairs because the flex shaft may fracture if bent repeatedly or beyond 90 degrees.
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 medical device with a mechanical defect that could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Standing Company is voluntarily recalling approximately 119 units of the Superstand stand-up wheelchair, model HPS-2. This device is a medical wheelchair intended to provide mobility to persons restricted to a sitting position by raising them to an upright position using an external manually controlled mechanical system.
The recall is due to a defect in the flex shaft, which is the flexible wand that supports the joystick control module. The FDA notes that the flex shaft may fracture if it is bent repeatedly and/or beyond 90 degrees. The Standing Company has developed a newly designed flex shaft that corrects this problem, which is available at no charge.
The affected units were distributed nationwide, including in Alabama, California, Delaware, Iowa, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, New Jersey, Ohio, Oklahoma, Texas, Washington, Wisconsin, and West Virginia. Consumers should check their serial numbers against the list provided in the official recall notice to determine if their device is affected.
The recalled product
- Product
- Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended…
- Manufacturer
- The Standing Company
- Category
- Medical Device — Mobility Aids
- Affected units
- 119
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 (20)
- Serial No: 1306
- 1313
- 1342
- 1349
- 1362
- 1358
- 1359
- 1392
- 1391
- 1406
- 1402
- 1407
- 1426
- 1441
- 1451
- 1018
- 1453
- 1399
- 1523
- 1477
Distribution
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