The Recall Desk
HighFDA (Devices)·Z-0503-2018·Announced 2018-02-07

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.

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 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.

See all 5 products in this recall →

Related recalls

Same manufacturer · Beaver-Visitec International Inc.

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Same hazard · cut injury

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