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 Cannula
- Model numbers
- Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043
- 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 25GA Subretinal Injection Cannula is used in ophthalmic surgeries for injecting medications into the subretinal space. It is essential for treating various retinal conditions.
Why This Is Dangerous
Voids in the seal of Tyvek pouches may compromise the sterility of the cannula, leading to a higher risk of infection due to potential contamination.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should immediately stop using the affected cannulas to prevent potential infections, which could lead to serious health complications.
Practical Guidance
How to identify if yours is affected
- Check the catalog number VS0220.25 on the product packaging.
- Look for any voids in the seal of the Tyvek pouches.
- Verify the lot number against those listed in the recall notice.
Where to find product info
Serial numbers and catalog numbers are typically found on the packaging and product label.
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
- Contact Vortex Surgical directly for updates.
- Document your communication attempts with the manufacturer.
How to prevent similar issues
- Always check for product recalls before using medical devices.
- Ensure packaging is intact and sterile before use.
- Consult healthcare providers regarding device safety.
Documentation advice
Keep records of your purchase, any correspondence with the manufacturer, and follow-up documentation regarding the recall.
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Product Details
The recalled product is the 25GA Subretinal Injection Cannula, catalog number VS0220.25. The recall includes lots identified through the manufacturer's notification letter.
Key Facts
- Recall Date: December 16, 2025
- Report Date: February 11, 2026
- Quantity Recalled: 14,789 units
- Distribution: Worldwide including the U.S. and multiple countries
- Hazard: Potential bioburden contamination
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Safety Guide
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