The Recall Desk
HighFDA (Devices)·Z-0501-2018·Announced 2018-02-07

Beaver Safety Sideport Knife Recalled Due to Retracted Protective Shield

Beaver-Visitec International Inc. is recalling specific batches of Beaver Safety Sideport 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 is classified as FDA Class II and involves a medical device defect (exposed blade) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' category per the rubric.

Plain-English summary

Beaver-Visitec International Inc. is recalling specific batches of bvi Beaver Safety Sideport Knives. The recall involves three product variations: 1.0mm, 45-degree (REF 378210); 1.2mm, 45-degree (REF 378212); and 115mm, 45-degree (REF 378231). 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The recall was initiated because the protective shield on the affected knives was retracted, leaving the blade exposed. This defect presents a safety risk during surgical procedures. The agency has classified this recall as Class II.

A total of 572,490 units are affected by this recall. The products were distributed worldwide, including nationwide in the United States and in Italy, the UK, Finland, Germany, Ireland, and Turkey. Users should check their inventory against the specific reference numbers and batch numbers listed in the official recall documentation to determine if they possess affected units.

The recalled product

Product
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 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
Affected units
572,490

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 (5)

  • (a) REF 378210
  • 1.0mm
  • 45o
  • 1.2mm
  • 115mm

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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