Beaver Xstar Crescent Knife surgical blades may have incorrect bevel angle
Approximately 5950 Beaver Xstar Crescent Knife surgical blades may be packaged with the wrong bevel angle, potentially affecting proper surgical technique during cataract procedures.
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: The source does not report any adverse events. This FDA Class II surgical device recall involves a configuration error (bevel-up blades packaged as bevel-down) that could affect surgical technique. Per the severity rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Beaver Visitec International is recalling Beaver Xstar Crescent Knife surgical blades (2.5mm, 55 degrees, reference 373809) intended for use in cataract surgery. Approximately 5950 units are affected across multiple lot numbers.
The recalled blades are packaged as bevel-down configuration but contain bevel-up blades instead. This configuration error could affect proper surgical technique and outcomes during cataract procedures.
The affected lot numbers are 6000842, 6002045, 6011609, 6034238, 6040517, and 6042907. The blades have been distributed nationwide and internationally to Australia, Austria, France, Germany, Netherlands, Spain, Japan, Russia, South Africa, and the United Kingdom.
Healthcare facilities should immediately stop use of affected blades and contact Beaver Visitec International. Surgeons should visually verify the blade bevel angle before use to ensure proper surgical technique.
The recalled product
- Product
- Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- configuration-error
- mis-labeling
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 (5)
- LOT#: 6000842
- 6002045
- 6011609
- 6034238
- 6040517
Distribution
Distributed nationwide across the United States.
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