Beaver Xstar Safety Crescent Blades Recalled Due to Exposed Blade
Beaver-Visitec is recalling 123,240 units of Xstar Safety Crescent blades because the protective shield retracted, exposing the blade.
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: The recall involves a medical device with a defect that exposes a sharp blade, creating a risk of injury during surgical use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beaver-Visitec International Inc. is recalling 123,240 units of bvi Beaver Xstar Safety Crescent blades (REF 378234). The recall involves specific batch numbers distributed worldwide, including the United States, Italy, the UK, Finland, Germany, Ireland, and Turkey.
The recall was initiated because the protective shield on the blades retracted, leaving the blade exposed. These specialty blades are used for stab and cut incisions in ophthalmic, ENT, and other surgical applications.
Healthcare facilities and distributors should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
- Manufacturer
- Beaver-Visitec International Inc.
- Category
- Medical Device — Surgical Blades
- Hazard
- Affected units
- 123,240
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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