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
- Polisher
- Model numbers
- Pouch UDI 817618024508 Box UDI 817618024508 Lot 2411013
- 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
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
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 Tecfen Retractable Membrane Polisher is a medical device used in various healthcare settings. It is designed to provide a sterile environment for medical procedures.
Why This Is Dangerous
Voids in the seal of Tyvek pouches can lead to compromised sterility, creating a pathway for potential contamination that may cause infection.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers using the affected device face a high risk of infection, which could necessitate medical intervention.
Practical Guidance
How to identify if yours is affected
- Check the product's catalog numbers and lots against the recall notice.
- Contact Vortex Surgical for confirmation of your device's status.
- Inspect the device for any visible damage or defects.
Where to find product info
Serial numbers and lot information can typically be found on the packaging or device itself.
What timeline to expect
Expect a processing time of 4-6 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Document all communication attempts with Vortex Surgical.
- Contact your healthcare provider for further advice.
- Reach out to regulatory agencies if necessary.
How to prevent similar issues
- Always verify the sterility of medical devices before use.
- Stay informed about product recalls through healthcare providers.
- Choose devices with clear safety certifications.
Documentation advice
Keep records of your purchase, correspondence with the manufacturer, and photos of the product.
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Product Details
The recalled product is the Tecfen Retractable Membrane Polisher, model QTPR1267-23, with associated catalog numbers and lots. It was distributed worldwide, including states in the US and several countries such as Australia, France, and Germany. The total quantity recalled is 14,789 units.
Key Facts
- Recall date: December 16, 2025
- Total units recalled: 14,789
- Distribution: Worldwide, including the US and 14 other countries
- Contact Vortex Surgical for recall instructions
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Safety Guide
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