Quick Facts at a Glance
- Recall Date
- November 19, 2025
- Hazard Level
- HIGH
- Brand
- Vortex Surgical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 19, 2025
Reported by FDA DEVICE
January 7, 2026
RecallRadar source check
January 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
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: E-Mail
About This Product
The Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe is a medical device used in surgical procedures. It is designed to assist in precise laser applications.
Why This Is Dangerous
The defect involves the probe's inability to pass smoothly through a 25ga cannula, which could hinder surgical procedures and increase the risk of complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should cease using the device immediately to avoid potential surgical complications. This recall may cause inconvenience for healthcare providers needing to replace these devices.
Practical Guidance
How to identify if yours is affected
- Check the catalog number on the product packaging.
- Verify the lot number against the recall notice.
- Contact Vortex Surgical if uncertain about the product's status.
Where to find product info
The catalog number and lot number can typically be found on the product box or pouch.
What timeline to expect
Expect the refund process to take approximately 4-6 weeks after the product is returned.
If the manufacturer is unresponsive
- Document all attempts to contact Vortex Surgical.
- Consider filing a complaint with the FDA if unresponsive.
How to prevent similar issues
- Always verify product recalls before use.
- Look for FDA approval and certification when purchasing medical devices.
- Consult healthcare professionals regarding device safety.
Documentation advice
Keep records of your correspondence with Vortex Surgical and any receipts for the device.
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Product Details
The recalled product is the Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25. It has been distributed in the US and Japan and falls under Class II classification.
Key Facts
- Distributed in the US and Japan
- Class II medical device
- Immediate stop-use required
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Safety Guide
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