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
- Convenience Kit
- Model numbers
- 1. 25GA Convenience Kit - FNX Pouch UDI 810123482917 Box UDI 810123482924 Lot 2410055 2. 25GA Convenience Kit - FXX Pouch UDI 810123482429 Box UDI 810123482443 Lot 2411028 3. 25GA Convenience Kit - XES Pouch UDI 810123482412 Box UDI 810123482436 Lot 2410057
- 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 Vortex Surgical Convenience Kits are used in medical settings for procedures requiring sterile instruments. They are purchased by healthcare providers for their convenience and efficiency in ensuring patient safety.
Why This Is Dangerous
Voids in the seal of Tyvek pouches can compromise the sterility of medical devices, increasing the risk of infections from bioburden contamination.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall could lead to significant health risks for patients if the products are used, requiring immediate action from healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check the model numbers against the recalled models: FNX (VS0644.25-FNX), FXX (VS0644.25-FXX), and XES (VS0644.25-XES).
- Look for the UDI and lot numbers on the packaging to confirm if your kit is affected.
- If unsure, contact Vortex Surgical for clarification.
Where to find product info
Serial numbers and lot codes can typically be found on the packaging of the convenience kits, often near the barcode or product description.
What timeline to expect
Expect a refund or replacement to take around 4-6 weeks once the return process is initiated.
If the manufacturer is unresponsive
- Document all contact attempts with Vortex Surgical.
- Consider reaching out to regulatory agencies like the FDA if the company remains unresponsive.
- Seek legal advice if necessary.
How to prevent similar issues
- Always verify the recall status of medical devices before use.
- Purchase medical supplies from reputable sources with safety certifications.
- Stay informed about product recalls through reliable health authority websites.
Documentation advice
Keep records of your purchase, any communications with the manufacturer, and documentation of the recall for your records.
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Product Details
The recall affects three models of 25GA Convenience Kits: FNX (VS0644.25-FNX), FXX (VS0644.25-FXX), and XES (VS0644.25-XES). These products were distributed in the U.S. and internationally, with a quantity of 14,789 units recalled.
Key Facts
- Recall date: December 16, 2025
- Class II recall
- Quantity recalled: 14,789 units
- Distribution: U.S. and worldwide
- Contact: Vortex Surgical Inc.
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Safety Guide
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