Pride Mobility Recalls TRU-Balance 3 Power Positioning Systems
Pride Mobility Products Corp is recalling 12,343 TRU-Balance 3 Power Positioning Systems because the back and tilt base can separate when tilted beyond the specified angle.
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 medical device that can cause injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pride Mobility Products Corp is recalling 12,343 units of the TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). These are mobility medical devices distributed nationwide.
The recall is being issued because the interface between the TB3 back and tilt base can separate when the device is tilted beyond the specified angle. This separation presents a risk of injury to the user.
Consumers who own these devices should stop using them immediately and contact Pride Mobility Products Corp for instructions on how to proceed with the recall.
The recalled product
- Product
- TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
- Manufacturer
- Pride Mobility Products Corp
- Category
- Medical Device — Mobility Aids
- Affected units
- 12,343
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 (2)
- Numerous serial numbers affected (12
- 343 units)
Distribution
Distributed nationwide across the United States.
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