Stryker Electric Hospital Beds Recalled for Unintended Home Use
Stryker recalled 9 Electric MedSurg Bed FL23 units intended for healthcare facilities but distributed to residential customers. Professional-level instructions may not be understood by untrained home users.
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: Class II medical device recall for a product being used in unintended home environments by users who may not understand professional-level instructions. No illnesses or injuries have been reported, but there is a risk-of-harm potential from improper use.
Plain-English summary
Stryker Medical Division of Stryker Corporation has recalled the Electric MedSurg Bed FL23, an electrically powered adjustable hospital bed with four built-in DC motors and remote controls. Nine units are affected.
These beds were designed and intended for use in healthcare facilities by trained professionals. However, they were distributed to and are currently in use in residential home environments. While the product's labeling correctly identifies the intended use in healthcare settings, home users may not be aware of or fully understand the instructions, which were designed specifically for healthcare professionals.
The recalled units have been distributed worldwide, including throughout the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.
The recalled product
- Product
- Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 9
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Stryker Medical Division of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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