S3 MedSurg hospital beds recalled from residential sale due to misuse risk
Stryker's S3 MedSurg hospital beds designed for healthcare facilities were distributed to home customers. The device labeling is correct but home users may not understand professional-use instructions, posing a risk of improper operation.
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 a risk-of-harm product (medical device for critical patient support) distributed outside its intended healthcare environment, creating potential for injury from improper use. No illnesses or injuries have been reported, placing it in the 'High' category per the rubric for unconfirmed risks with Class II devices.
Plain-English summary
Stryker Medical has recalled 21 units of the S3 MedSurg Bed (Model 3002, including variants 3002S3CUSTOM, 3002S3EX, and 3002S3PATRIOT). These are medical devices designed to support and transport patients in hospital critical care and medical/surgical units.
The recalled units were distributed to residential customers instead of healthcare facilities. While the product labeling correctly identifies the intended use environment, home users may not be aware of or fully understand instructions intended for healthcare professionals. Using a hospital-grade bed without professional setup and training poses a risk of injury from improper use.
The affected units have been distributed worldwide, including throughout the United States and in Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, and Thailand. Affected serial numbers are listed in the FDA recall notice.
If you own one of these beds, verify the serial number against the official recall notice. Do not use the device in a home environment without professional medical oversight and proper training. Contact Stryker Medical with your serial number for appropriate next steps.
The recalled product
- Product
- S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- improper-use-risk
- insufficient-training
- patient-safety-risk
Distribution
Distributed nationwide across the United States.
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