FDA-Device2026-02-11Class IIPACKAGING DEFECT

Vortex Surgical Tecfen Retractable Membrane Polisher recalled for compromised sterile packaging

Nationwide distributionMedical devices

What this means

Vortex Surgical Inc. is recalling Tecfen Retractable Membrane Polisher units (lot 2411013) because the Tyvek sterile pouches may have seal voids that compromise the sterile barrier. This could allow bacterial contamination and increase the risk of infection if the device is used.

Stop using the affected polisher (lot 2411013, UDI 817618024508) immediately.
Contact Vortex Surgical Inc. or your supplier for instructions on return or replacement.
If you have already used this device, contact your healthcare provider or infection control department.

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.

Affected count

14,789 (8651 US; 6138 OUS)

Manufactured in

4 Research Park Dr Ste 124, N/A, Saint Charles, MO, United States

Products

Tecfen Retractable Membrane Polisher, QTPR1267-23

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2026

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