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
- Internal Delivery Device
- Model numbers
- Pouch UDI 810123480456 Box UDI 810123480739 Lot 2410044
- 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 Vortex Surgical 25GA I.D.D. Internal Delivery Device is used in medical procedures to assist with internal delivery applications. Healthcare providers rely on its sterility for safe patient outcomes.
Why This Is Dangerous
Voids in the seal of Tyvek pouches can compromise the device's sterile barrier, potentially allowing harmful microorganisms to contaminate the device and lead to infection.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers and healthcare providers must act swiftly to prevent potential infections. The recall poses significant safety concerns, necessitating immediate cessation of use and return of the device.
Practical Guidance
How to identify if yours is affected
- Check the catalog number and lot information on the packaging.
- Verify if your device matches the identified models for the recall.
- Review any communication from Vortex Surgical regarding the recall.
Where to find product info
Product identification information, including catalog numbers and lots, can typically be found on the packaging or accompanying documentation.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Document your correspondence with Vortex Surgical.
- Follow up with phone calls or emails if you do not receive a response within a reasonable timeframe.
- Consider filing a complaint with the FDA if necessary.
How to prevent similar issues
- When purchasing medical devices, ensure they are from reputable manufacturers.
- Look for FDA approval or clearance labels.
- Confirm that packaging is intact and sterile before use.
Documentation advice
Keep records of your purchase, any communications regarding the recall, and photos of the device as evidence.
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Product Details
The recalled product is the Vortex Surgical 25GA I.D.D. Internal Delivery Device, model VS0250.25. It was sold worldwide, including in the US and various foreign countries, with a total of 14,789 units recalled. The affected catalog number includes Pouch UDI 810123480456 and Box UDI 810123480739, Lot 2410044.
Key Facts
- Recalled product: Vortex Surgical 25GA I.D.D. Internal Delivery Device
- Total units recalled: 14,789
- Recall initiated on: December 16, 2025
- Potential for bioburden contamination
- Immediate action required: Stop using the device
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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