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
- Injection Kit
- Model numbers
- Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012
- 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 I2 Injection Kit is used in medical settings for injections and procedures requiring sterile conditions. Healthcare providers purchase this product to ensure safe and effective medical treatments.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers and healthcare providers must act swiftly to prevent potential infections. The recall may cause disruptions in medical procedures that rely on this product.
Practical Guidance
How to identify if yours is affected
- Check if you have the Vortex Surgical I2 Injection Kit, model VS0500.
- Verify the Pouch UDI and Box UDI against the recalled identifiers.
- Look for Lot 2411012 on the product packaging.
Where to find product info
The Pouch UDI and Box UDI can be found printed on the product packaging or the accompanying documentation.
What timeline to expect
Expect a refund or replacement to be processed within 4-6 weeks after following the recall instructions.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Always check for recalls on medical devices before purchasing.
- Look for certification marks ensuring product sterility and safety.
- Research the manufacturer’s reputation for product quality.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
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Product Details
The recalled product is the Vortex Surgical I2 Injection Kit, model VS0500. The affected lot includes Pouch UDI 810123480920 and Box UDI 810123481330, Lot 2411012. It was distributed worldwide, including across the U.S. to 21 states.
Key Facts
- Recall date: December 16, 2025
- Quantity recalled: 14,789 units
- Distribution: Worldwide, including U.S. and multiple countries
- Potential contamination risk linked to compromised sterility
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Safety Guide
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