[pending] Tecfen Retractable Membrane Polisher, QTPR1267-23
Pending LLM rewrite. Source: FDA_DEVICE Z-1251-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Tecfen Retractable Membrane Polisher, QTPR1267-23
- Manufacturer
- Vortex Surgical Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Pouch UDI 817618024508 Box UDI 817618024508 Lot 2411013
Distribution
Distributed nationwide across the United States.
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