The Recall Desk
HighFDA (Devices)·Z-0500-2018·Announced 2018-02-07

Beaver-Visitec Recalls Safety Knives Due to Retracted Protective Shield

Beaver-Visitec International Inc. is recalling specific EdgeAhead Safety Knives 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 where the safety shield failed, exposing the blade. This is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Beaver-Visitec International Inc. is recalling specific models of the bvi Beaver EdgeAhead Safety Knife. The affected products include the Sideport MVR .90mm 20G (REF 370531) and the Sideport Angled, .60mm (23G) (REF 378233). These specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT, and other surgical applications.

The recall was initiated because the protective shield on the devices was retracted, leaving the blade exposed. This condition presents a risk of injury to users during surgical procedures. The recall involves 45,680 units distributed worldwide, including the United States, Italy, the UK, Finland, Germany, Ireland, and Turkey.

Healthcare professionals and patients who have used these specific devices should contact Beaver-Visitec International Inc. for instructions on how to return the product or obtain a replacement. Specific batch numbers for the affected units are listed in the official recall documentation.

The recalled product

Product
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 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 Instruments
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 (2)

  • (a) REF 370531
  • Batch numbers: 3191985 3204382 3225442

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 →

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Same manufacturer · Beaver-Visitec International Inc.

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