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 Device
- Model numbers
- Pouch UDI 5060720920298 Box UDI 5060720920298 Lot 2411033
- 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 Disposable Diamond Dusted ILM Elevator is a surgical device used in medical procedures to elevate tissues. Healthcare providers often use it for precision during surgeries.
Why This Is Dangerous
Voids in the seal of the Tyvek pouches can compromise the sterile barrier, increasing the risk of contamination. This can potentially expose patients to infections during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face serious health risks due to potential infections. Immediate action is required to prevent use of a compromised medical device.
Practical Guidance
How to identify if yours is affected
- Check the catalog number 12-7523 on your device.
- Inspect the Tyvek pouch for any visible signs of seal voids.
- Verify the lot number against the recall notice.
Where to find product info
The catalog number and lot number can typically be found on the product packaging or the device itself.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks after contacting Vortex Surgical.
If the manufacturer is unresponsive
- Document all communications with the company.
- Reach out to the FDA for further assistance.
- Consider contacting a consumer protection agency.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Look for visible seals and certifications on packaging.
- Purchase from reputable suppliers.
Documentation advice
Keep records of your purchase, communications with the manufacturer, and any relevant medical records.
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Product Details
The recalled model is the Disposable Diamond Dusted ILM Elevator, catalog number 12-7523. It distributed worldwide, including 8,651 units in the U.S. The product was sold prior to the recall date.
Key Facts
- Recalled model: Disposable Diamond Dusted ILM Elevator, 12-7523
- Total recalled units: 14,789
- Potential contamination risk due to seal voids
- Immediate cessation of use advised
- Contact Vortex Surgical for further instructions
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Safety Guide
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