Quick Facts at a Glance
- Recall Date
- November 17, 2025
- Hazard Level
- HIGH
- Brand
- Sophysa
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Sophysa
- Product type
- Intracranial Pressure Monitor
- Model numbers
- PSO-4000, UDI/DI 03760124132076
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 17, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Customer complaints of Pressio monitor rebooting.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Sophysa or your healthcare provider for instructions
About This Product
The Pressio 2 ICP Monitoring System is designed for monitoring intracranial pressure in patients, primarily used in hospitals and clinical settings. It is critical for managing patients with conditions affecting brain pressure.
Why This Is Dangerous
The rebooting issue in the Pressio monitor can cause loss of monitoring capabilities, potentially compromising patient safety. This defect may lead to delayed responses in critical situations.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers need to act quickly to prevent risks associated with the monitor's malfunction. The urgency is high, as improper monitoring can have severe health implications.
Practical Guidance
How to identify if yours is affected
- Check the model number on the back of the device.
- Ensure your model is PSO-4000 to confirm if it is affected.
- Look for any recent complaints or notices from your healthcare provider regarding this device.
Where to find product info
The model number can typically be found on the device's label or in the user manual.
What timeline to expect
Expect a response for refunds or replacements within 4-6 weeks after contacting Sophysa.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Reach out to your healthcare provider for assistance.
- Consider reporting the issue to the FDA if unresolved.
How to prevent similar issues
- When purchasing medical devices, ensure they have thorough reviews and safety certifications.
- Stay updated on recalls by subscribing to health safety bulletins.
- Discuss any concerns regarding medical devices with healthcare professionals before use.
Documentation advice
Keep records of all communications with the manufacturer, including emails, phone calls, and any receipts related to the purchase.
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Product Details
The Pressio 2 ICP Monitoring System, Model Number PSO-4000, is designed for monitoring intracranial pressure. It was distributed nationwide in states including Arizona, Wisconsin, Texas, Oregon, California, Oklahoma, Idaho, Florida, and New Jersey.
Key Facts
- Rebooting issue poses health risks
- Distributed in multiple U.S. states
- Immediate discontinuation of use recommended
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Safety Guide
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