Surgical Crescent Knife Recalled for Incorrect Blade Orientation Labeling
Beaver Visitec International is recalling bvi CustomEyes Kits containing Crescent Knives due to incorrect labeling. Products labeled as 55-degree bevel-down blades actually contain bevel-up blades.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Class II medical device with a labeling/contents mismatch on a precision surgical instrument. While no illnesses or injuries have been reported, the mislabeling creates a risk-of-harm scenario where users could unknowingly use the incorrect blade orientation, potentially affecting surgical precision.
Plain-English summary
Beaver Visitec International is recalling bvi CustomEyes Kits containing Beaver Xstar Crescent Knives (lot number 6018382) due to labeling that does not match the actual product. The products are labeled as having 55-degree bevel-down blades but contain bevel-up blades instead.
This mismatch between labeling and actual product contents represents a risk for users who rely on the package label to identify the correct blade type for their intended surgical use.
Two units of the affected product were distributed nationwide and internationally, including to Australia, Austria, France, Germany, the Netherlands, Spain, Japan, Russia, South Africa, and the United Kingdom. The product is non-sterile and designated for evaluation purposes only.
Recipients should not rely on the package labeling to determine blade orientation and should verify the actual blade configuration of the product received.
The recalled product
- Product
- bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 2
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)
- Lot Number 6018382
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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