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. 23GA Laser Probe Curved Pouch UDI 810123480036 Box UDI 810123480180 Lot 2411027 2. 25GA Laser Probe Curved Pouch UDI 810123480043 Box UDI 810123480197 Lot 2411026 3. 25GA Laser Probe Flex-Tip Pouch UDI 810123480111 Box UDI 810123480265 Lot 2411024 2411031 4. 25GA Laser Probe Illuminated Curved Pouch UDI 810123480098 Box UDI 810123480241 Lot 2411025 5. 25GA Laser Probe MaxReach Pouch UDI 810123480135 Box UDI 810123480289 Lot 2410029 2411023 6. 25GA Laser Probe Straight Pouch UDI 810123480012 Box UDI 810123480166 Lot 2411030
- 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
Vortex Surgical laser probes are used in various medical procedures for precision and effectiveness. These devices are critical for healthcare providers during surgeries and other interventions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience for healthcare providers and patients, requiring immediate attention to ensure safety and prevent potential infections.
Practical Guidance
How to identify if yours is affected
- Check the catalog number on the product packaging.
- Verify the lot numbers against the recall list provided by Vortex Surgical.
- Consult your healthcare provider if you are unsure about the product's status.
Where to find product info
The catalog numbers and lot numbers are located on the Tyvek pouches and the product packaging.
What timeline to expect
Expect a response regarding refund or replacement within 4-6 weeks after initiating the recall process.
If the manufacturer is unresponsive
- Keep records of all communication with Vortex Surgical.
- Contact the FDA for further assistance if the company does not respond.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Ensure that medical products have intact packaging and seals before use.
- Stay informed about product safety alerts from manufacturers and regulatory agencies.
Documentation advice
Keep a record of the product details, any correspondence regarding the recall, and medical documents related to its use.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall includes the following catalog numbers: 23GA Laser Probe Curved (VS0120.23), 25GA Laser Probe Curved (VS0120.25), 25GA Laser Probe Flex-Tip (VS0130.25), 25GA Laser Probe Illuminated Curved (VS0125.25B), 25GA Laser Probe MaxReach (VS0140.25), and 25GA Laser Probe Straight (VS0110.25). These products were distributed in the U.S. and internationally to various countries.
Key Facts
- Recall date: December 16, 2025
- Affected quantity: 14,789 units
- Classification: Class II
- Distribution: Worldwide, including the US and multiple countries
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.