Quick Facts at a Glance
- Recall Date
- December 16, 2025
- Hazard Level
- HIGH
- Brand
- Vortex Surgical
- 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
- Vortex Surgical
- Product type
- Illuminated Depressor
- Model numbers
- Pouch UDI 810123481309 Box UDI 810123481712 Lot 2403027R
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 16, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
XXX
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vortex Surgical Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Vortex Surgical TID Pharos Illuminated Depressor is a medical device used in surgical settings to provide illumination during procedures. Healthcare providers purchase it for its functionality in enhancing visibility during operations.
Why This Is Dangerous
The specific hazard has not been disclosed, but the Class II recall indicates a potential for adverse health effects. Users should cease use immediately to mitigate risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience for healthcare providers relying on this device for procedures. The high hazard level raises significant safety concerns for patient care.
Practical Guidance
How to identify if yours is affected
- Check model number: VS0801B.
- Verify purchase location and date against recall details.
- Consult with healthcare provider regarding use.
Where to find product info
Model number can typically be found on the device packaging or documentation.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Follow up via phone or email if no response is received within 2 weeks.
- Consider filing a complaint with the FDA if the issue persists.
How to prevent similar issues
- Look for devices with established safety records and certifications.
- Check for recalls before purchasing medical devices.
- Consult with healthcare professionals about device safety.
Documentation advice
Keep records of all correspondence, including emails and letters from the manufacturer. Document the date of purchase and any health issues experienced.
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Product Details
The recalled product is the Vortex Surgical TID Pharos Illuminated Depressor, model VS0801B. It was distributed worldwide, with significant distribution in the U.S. states including California, Florida, and New York. The units were sold in various international markets including Australia, Germany, and Japan.
Key Facts
- Recall date: December 16, 2025
- Report date: February 11, 2026
- Quantity recalled: 14,789 units
- Hazard level: High risk
- Distribution: U.S. and multiple countries worldwide
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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