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
- Laser Probe
- Model numbers
- 1. 23G Laser Probe OS4 Flex-Tip Pouch UDI 810123483716 Box UDI 810123483792 Lot 2410031 2. 23G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483730 Box UDI 810123483815 Lot 2410034 3. 23G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483761 Box UDI 810123483846 Lot 2410033 4. 25G Laser Probe OS4 Flex-Tip Pouch UDI 810123483723 Box UDI 810123483808 Lot 2410032 2410058 2411022, 5. 25G Laser Probe OS4 Illuminated Flex-Tip Pouch UDI 810123483747 Box UDI 810123483822 Lot 2410035 6. 25G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483778 Box UDI 810123483853 Lot 2412025 7. 27G Laser Probe OS4 Intuitive Exendable Pouch UDI 810123483785 Box UDI 810123483860 Lot 2411021
- 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 Oertli Laser Probes are used in various medical procedures, providing precision during surgeries. Healthcare providers purchase these devices for their reliability in minimally invasive surgeries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall could delay medical procedures for patients relying on these devices, thus creating potential health risks.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device packaging.
- Check the lot number against the recall notice.
- Confirm if the pouch seal is intact.
Where to find product info
Model and lot numbers can typically be found on the outer packaging or the device's labeling.
What timeline to expect
Expect a refund processing timeline of 4-6 weeks after returning the device.
If the manufacturer is unresponsive
- Reach out via the contact information provided in the recall notice.
- Keep records of all communications.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Ensure packaging is intact when purchasing medical devices.
- Purchase from reputable suppliers.
Documentation advice
Keep all receipts, correspondence, and photographs of the device as records.
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Product Details
The recall includes several models: 23G Laser Probe OS4 Flex-Tip VK401113, 23G Laser Probe OS4 Illuminated Flex-Tip VK401213, 23G Laser Probe OS4 Intuitive Extendable VK401323, 25G Laser Probe OS4 Flex-Tip VK401115, 25G Laser Probe OS4 Illuminated Flex-Tip VK401215, 25G Laser Probe OS4 Intuitive Extendable VK401325, and 27G Laser Probe OS4 Intuitive Extendable VK401327. The probes were sold worldwide, including in the U.S. states of Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North car
Key Facts
- Recall date: December 16, 2025
- Total recalled units: 14,789
- Affected regions: Worldwide, including U.S. and several foreign countries
- Potential risk: Infection due to compromised sterile barrier
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Safety Guide
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