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
- Scleral Marker
- Model numbers
- Pouch UDI 810123483655 Box UDI 810123483662 Lot 2408035
- 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 Lindsell Sutured IOL Marker is used in ophthalmic surgeries to mark the position for intraocular lens placement. Surgeons rely on the sterility of this product to ensure patient safety during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may inconvenience healthcare providers and patients awaiting surgery, but it is essential for maintaining safety standards.
Practical Guidance
How to identify if yours is affected
- Check the catalog number on the device packaging.
- Verify if the lot number matches the recalled lots.
- Contact your healthcare provider for assistance.
Where to find product info
The catalog number and lot number can usually be found on the packaging or the product itself.
What timeline to expect
Expect a response regarding the recall process within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Vortex Surgical via phone or email.
- Consider reporting your issue to the FDA if you do not receive a timely response.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Ensure that the packaging of medical devices is intact and sterile before use.
Documentation advice
Document all communications with the manufacturer, retain receipts, and keep a record of the product details.
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Product Details
The recalled product is the Vortex Surgical Lindsell Sutured IOL Marker, model VS0390. It is distributed worldwide, with 8,651 units in the US and 6,138 units outside the US.
Key Facts
- Recall date: December 16, 2025
- Report date: February 11, 2026
- Quantity recalled: 14,789 units
- Affected catalog numbers: VS0390
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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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