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
- Forceps and Cannula
- Model numbers
- 1. 23GA ACTU8 Forceps Adaptive Pouch UDI 810123481125 Box UDI 810123481538 Lot 2411009 2. 25GA ACTU8 Forceps Adaptive Pouch UDI 810123481132 Box UDI 810123481545 Lot 2410051 3. 25GA ACTU8 Forceps ILM Pouch UDI 810123481231 Box UDI 810123481644 Lot 2410021 2410053 2411006 4. 25GA ACTU8 Forceps ILM -Myopic Pouch UDI 810123481248 Box UDI 810123481651 Lot 2410059 5. 25GA ACTU8 Forceps Pro-Grip Pouch UDI 810123481101 Box UDI 810123481514 Lot 2410050 2411011 6. 25GA ACTU8 Talon Forceps ILM Pouch UDI 810123481835 Box UDI 810123481859 Lot 2411003 7. 25GA ACTU8 Talon Forceps Pro-Grip Pouch UDI 810123482375 Box UDI 810123482405 Lot 2410060 8. 27GA ACTU8 Forceps ILM Pouch UDI 810123481255 Box UDI 810123481668 Lot 2410054 9. 23GA Soft Tip Cannula UDI Pouch 810123480302 Box UDI 810123480562 Lot 2410037 10. 23GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480388 Box UDI 810123480661 Lot 2411032 11. 25GA Soft Tip Cannula UDI Pouch 810123480319 Box UDI 810123480586 Lot 2410039 12. 25GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480395 Box UDI 810123480678 Lot 2410041 13. 25GA Soft Tip Cannula - 0.5mm - Bulk UDI Pouch 810123480395 Box UDI 810123481927 Lot 2410042 2411018 14. 25GA Soft Tip Cannula-Bulk UDI Pouch 810123480319 Box UDI 810123480593 Lot 2410040 15. 27GA Soft Tip Cannula UDI Pouch 810123480326 Box UDI 810123480609 Lot 2412026
- 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 Disposable Forceps and Cannula are medical devices used in various surgical procedures for grasping and manipulating tissue. These devices are essential for ensuring precision during surgeries and are widely utilized in healthcare settings.
Why This Is Dangerous
The recall is due to voids in the seal of Tyvek pouches, which can compromise the sterility of the devices. If the devices are not sterile, they may introduce pathogens into the surgical site, leading to infections.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The potential for bioburden contamination presents a serious health risk, necessitating immediate action from users to prevent infection.
Practical Guidance
How to identify if yours is affected
- Check the catalog numbers and lots on your device packaging against the recalled models.
- Verify the UDI numbers listed in the recall notice.
- Consult your healthcare provider if you are unsure about the product's status.
Where to find product info
Look for serial numbers and UDI codes printed on the packaging of the forceps and cannula.
What timeline to expect
Expect a realistic timeline of 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Contact Vortex Surgical Inc. via phone or email for follow-up.
- Document all communications regarding your refund request.
How to prevent similar issues
- When buying medical devices, ensure they have intact seals and proper certification.
- Check for recent recalls on healthcare products before purchase.
- Look for trusted brands with a history of compliance.
Documentation advice
Keep records of your purchase, any communications related to the recall, and photographs of the device.
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Product Details
The recall includes 15 models of disposable forceps and cannula, such as the 23GA ACTU8 Forceps Adaptive (VS0740.23) and the 25GA Soft Tip Cannula (VS0200.25). These products were sold worldwide, including in U.S. states like CA and NY, as well as countries such as Germany and Japan. The price range for these devices was not specified.
Key Facts
- Recall date: December 16, 2025
- Total units recalled: 14,789
- Affected models include 23GA and 25GA forceps
- Risk of bioburden contamination leading to infection
- No reported injuries or infections
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Safety Guide
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