Invacare Homecare and G-Series Bed Components Recalled for Weld Defects
Invacare Corporation is recalling approximately 8,117 bed component units nationwide due to a potential weld defect that may cause premature weld failure.
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: This is a structural defect in medical device bed components classified as FDA Class II. The source describes a risk-of-harm product (weld defects leading to potential structural failure) without any reported injuries or illnesses, placing it at High severity per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Invacare Corporation is recalling Homecare Series Beds and G-Series Beds containing component model numbers G50, G53, G54, BAR5490IVC, BAR5000IVC, 5000IVC, 5490IVC, and 5490LOW distributed nationwide. Approximately 8,117 units are affected.
The components have been identified with a potential weld defect that can lead to premature weld failures in the bed structure.
No injuries or illnesses have been reported in connection with this defect.
The recalled product
- Product
- Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
- Manufacturer
- Invacare Corporation
- Affected units
- 8,117
Distribution
Distributed nationwide across the United States.
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