Xstar Safety Slit Knife Recalled for Incorrect Blade Bevel Orientation
Beaver Visitec International is recalling the Xstar Safety Slit Knife Model 378227 because some units have the blade bevel installed incorrectly—facing downward instead of the intended upward orientation.
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: This is a risk-of-harm medical device (surgical instrument) with incorrect configuration that affects its intended function. While FDA Class II devices typically require hospitalization reports for a Severe rating, no injuries have been reported. The incorrect blade orientation presents a potential hazard to users, but the absence of reported incidents places this at the High level per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
The Xstar Safety Slit Knife Model 378227 is a surgical instrument manufactured by Beaver Visitec International, Inc. The recall involves approximately 1,300 units distributed worldwide, including the United States, Canada, United Kingdom, and Italy, with Lot Number 6058854.
The device has been recalled due to incorrect blade bevel configuration. Affected units have the blade bevel positioned on the opposite side from the intended design: the bevel is facing downward (bevel down) instead of the specified upward orientation (bevel up). This configuration error affects the proper function of the surgical instrument.
The recalled product
- Product
- Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device
- Hazard
- incorrect-blade-orientation
- surgical-use-hazard
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 (2)
- UDI-DI: 00886158001652
- Lot Number: 6058854
Distribution
Distributed nationwide across the United States.
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