Stryker GoBed II Medical Bed Recalled for Improper Home Distribution
Stryker's GoBed II MedSurg Bed was distributed to residential customers but is intended for healthcare facility use. Home users may not understand professional-level safety instructions, creating a risk of misuse.
What this means for you
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 an FDA Class II recall involving medical equipment intended for healthcare professional use that was incorrectly distributed to residential customers. Although no injuries have been reported, there is a risk of harm from potential misuse by untrained home users unfamiliar with professional-level safety instructions.
Plain-English summary
The GoBed II MedSurg Bed, Model Number FL28 (Part #FL28EX), manufactured by Stryker Medical Division of Stryker Corporation, is a medical device intended exclusively for use in healthcare facilities. Thirty-three units have been distributed worldwide, including across the United States and to Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand.
These medical beds were distributed to residential customers for home use. The product labeling correctly identifies the intended use environment as healthcare facilities, but home users may not be aware of or fully understand the safety instructions and operation protocols designed for trained healthcare professionals. This distribution to an unintended and unprepared user population creates a potential risk of misuse and safety issues.
The affected units can be identified by specific serial numbers and UDI codes.
The recalled product
- Product
- GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Category
- Medical Device
- Hazard
- improper-use
- lack-of-training
Distribution
Distributed nationwide across the United States.
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