Invacare Recalls G-Series Bed Rails Due to Entrapment Safety Defect
Invacare is recalling G-Series bed rails because the mounting bracket does not meet entrapment safety specifications.
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 safety defect related to entrapment, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Invacare Corporation is recalling approximately 2,499 units of G-Series Beds, specifically the G29 full length bed rails assembly. The recall was initiated because the rail mounting bracket was identified as being out of specification for entrapment safety.
The affected products were distributed nationwide in the United States, including in Ohio, Colorado, Missouri, and New York. The recall covers Model G5510 units with specific date codes ranging from 40121 to 40904.
Consumers and healthcare facilities should stop using the affected bed rails and contact Invacare for instructions on how to proceed with the recall.
The recalled product
- Product
- G- Series Beds; G29 full length bed rails assembly
- Manufacturer
- Invacare Corporation
- Category
- Medical Device — Hospital Bed
- Hazard
- Affected units
- 2,499
Distribution
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