Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tecfen Retractable Membrane Polisher Recalled by Vortex Surgical Inc. Due to There may be voids located in the seal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vortex Surgical Inc. directly.
Affected Products
Tecfen Retractable Membrane Polisher, QTPR1267-23
Quantity: 14,789 (8651 US; 6138 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vortex Surgical Inc.
Vortex Surgical Inc. has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report