Stryker Rose Bed Siderail Latch Failure Recall
Stryker is recalling Model FL14E Rose Beds because siderails may appear latched when they are not, posing a risk of patient injury.
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 risk-of-harm product (medical bed) where injury (bruises, lacerations, falls) has not yet been reported as a confirmed incident in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling Model FL14E Rose Beds. The Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and latchable siderails.
The recall is due to reports that the siderail may appear latched when it is not, due to a lack of proper preventive maintenance. This condition might result in bruises and/or lacerations to a patient who is leaning against the siderails if the siderail releases. Additionally, the siderail may not effectively constrain a patient to prevent them from rolling or falling off the bed.
The affected units were distributed worldwide, including nationwide in the USA and internationally to Canada, Japan, South America, Latin America, and China. The source text does not specify the number of affected units, specific lot numbers, or dates of distribution.
The recalled product
- Product
- Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and…
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device — Hospital Bed
Distribution
Distributed nationwide across the United States.
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