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
- Surgical Backflush Pouch
- Model numbers
- 25GA Backflush Pouch UDI 810123480470 Box UDI 810123480753 Lot 2411017, 27GA Backflush Retractable Pouch UDI 810123480517 Box UDI 810123480791 Lot 2411016
- 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 backflush pouches are used in medical procedures to ensure a sterile environment during surgeries. They are essential for maintaining hygiene and preventing infections in patients.
Why This Is Dangerous
The voids in the seal of Tyvek pouches can compromise the sterility of the contents, increasing the risk of bioburden contamination. This contamination can lead to serious infections in patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a significant safety concern, as using contaminated medical devices could lead to infections, which may require treatment and could impact patient health.
Practical Guidance
How to identify if yours is affected
- Check the catalog numbers: VS0270.25 and VS0275.27.
- Inspect the packaging for any signs of damage or voids in the seals.
- Review purchase records to confirm if you have the recalled pouches.
Where to find product info
Look for the catalog number and lot information on the box or pouch itself.
What timeline to expect
Expect refund processing to take 4-6 weeks.
If the manufacturer is unresponsive
- Contact Vortex Surgical directly via their customer service number.
- Document all communication attempts in case of further escalation.
How to prevent similar issues
- Always check for recalls on medical devices before purchase.
- Look for certified sterile packaging when buying surgical supplies.
- Consult with healthcare professionals regarding the safety of medical devices.
Documentation advice
Keep receipts, communication records with the manufacturer, and take photographs of the product in case of disputes.
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Product Details
The recall involves Vortex Surgical 25GA Backflush Pouches (Catalog Number VS0270.25) and 25GA Backflush Retractable Pouches (Catalog Number VS0275.27). These products were distributed worldwide, including all U.S. states and multiple foreign countries, and were sold in quantities of 14,789, with 8,651 in the U.S. and 6,138 internationally.
Key Facts
- Recall date: December 16, 2025
- Report date: February 11, 2026
- Quantity recalled: 14,789 units
- Affected catalog numbers: VS0270.25, VS0275.27
- Distribution: Worldwide, including all U.S. states
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Safety Guide
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