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
- Vitrectomy Lens
- Model numbers
- 1. Flat Vitrectomy Lens Pouch UDI 810123482290 Box UDI 810123482306 Lots 2410036 2411020 2. Volk Magnifying Lens Pouch UDI 810123482825 Box UDI 810123482832 Lot 2411019
- 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
Vitrectomy lenses are surgical devices used in eye surgeries to assist in procedures involving the retina and vitreous. Medical professionals purchase these lenses for their critical roles in delicate eye surgeries.
Why This Is Dangerous
Compromised seals in the Tyvek pouches can lead to contamination, posing a significant health risk during surgeries. This increases the likelihood of infections that could severely affect patient outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face potential health risks due to possible infections. The immediate cessation of use is necessary to mitigate this risk.
Practical Guidance
How to identify if yours is affected
- Check the catalog number and lot numbers against the recall notice.
- Inspect packaging for any signs of compromised seals.
- Contact the manufacturer or healthcare provider for further guidance.
Where to find product info
Look for the catalog number and lot number on the packaging of the vitrectomy lenses.
What timeline to expect
Expect a processing time of 4-6 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Document your attempts to contact the company.
- Consider reaching out to the FDA for assistance if you do not receive a response.
How to prevent similar issues
- Always check for recall notices before using medical devices.
- Ensure sterile packaging is intact before use.
- Consult with healthcare providers about the safety of medical devices.
Documentation advice
Keep records of purchase receipts, communications with the manufacturer, and any medical symptoms experienced.
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Product Details
The recall includes two models: Flat Vitrectomy Lens, Catalog VFD and Volk Magnifying Lens, Catalog VMD. The affected products were distributed in the U.S. and internationally, with specific lots identified for recall.
Key Facts
- Recall date: December 16, 2025
- Quantity recalled: 14,789 lenses
- Affected states: AL, AR, CA, FL, TX and others
- International distribution includes countries like Australia, Germany, UK
- High hazard level due to potential for infection
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Safety Guide
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