Vortex Surgical recalls Tecfen Retractable Membrane Polisher model QTPR1267-23 due to potential voids in Tyvek pouch seals that could cause infection. Affected units have specific catalog numbers and lots.
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.
Vortex Surgical is recalling Tecfen Retractable Membrane Polishers with model QTPR1267-23 because the Tyvek pouch seals might have voids that could lead to infection. This is serious because medical devices must stay sterile to prevent infections during procedures.
The Tyvek pouches used to maintain sterility may have small holes or gaps in the seal. If these voids allow contaminants to enter, they could cause infections during medical procedures.
Healthcare professionals using this surgical device are most at risk. Patients undergoing procedures with this device could be exposed to infection if the pouch seal is compromised.
Check for the model number QTPR1267-23 on the device. Affected units have a Pouch UDI 817618024508 and Box UDI 817618024508 with lot number 2411013.
Look for the model number QTPR1267-23 and the specific UDI and lot numbers listed in the recall notice.
The recall states that there may be voids in the seal that could lead to infection, so it is not safe to use without checking the recall status.
Check for the model number QTPR1267-23 with Pouch UDI 817618024508 and Box UDI 817618024508 lot 2411013.
The recall does not specify a remedy, so contact Vortex Surgical directly for guidance.
We’ve drafted a message you can send Vortex Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1251-2026 — Vortex Surgical Vortex Surgical Hello, I own a Vortex Surgical that is covered by recall Z-1251-2026 from Vortex Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
