Beaver Xstar Slit Knife Recalled for Size Mismatch Labeling
Beaver Visitec is recalling 196 boxes of Xstar Slit Knives because the package label indicates a 2.4 mm size, while the device marking shows 2.75 mm.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error (size mismatch) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Beaver Visitec is recalling 196 boxes (10 units per box) of Beaver Xstar Slit Knife 2.4 mm, 45-degree Double Bevel, REF # 370824. The recall is due to a labeling discrepancy where the package indicates a 2.4 mm size, but the marking on the device itself shows a 2.75 mm size.
The affected product is utilized in ophthalmic techniques for cataract and glaucoma procedures. The distribution pattern includes worldwide distribution, specifically the United States nationwide, the United Kingdom, Japan, and the Netherlands. The specific lot number for this recall is 6008554.
Healthcare providers and facilities should stop using the affected devices and contact Beaver Visitec for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
- Manufacturer
- Beaver Visitec
- 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 (1)
- Lot Number: 6008554
Distribution
Distributed nationwide across the United States.
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