The Recall Desk
HighFDA (Devices)·Z-0504-2018·Announced 2018-02-07

Beaver Optimum Safety Sideport Knife Recalled Due to Retracted Shield

Beaver-Visitec is recalling 526,220 units of Optimum 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 involves a medical device with a defect that exposes a sharp blade, creating a risk of harm during surgery. As no specific injuries or illnesses are reported in the source text, it falls under the 'High' category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Beaver-Visitec International Inc. is recalling 526,220 units of bvi Beaver Optimum Safety Sideport Knives. The affected products include four straight blade angles (15°, 22.5°, 30°, and 45°) with reference numbers 378235, 378236, 378237, and 378238. These specialty blades are used for stab and cut incisions in ophthalmic, ENT, and other surgical applications.

The recall was initiated because the protective shield on the knives was retracted, leaving the blade exposed. This defect presents a safety risk during surgical procedures. The agency classification for this recall is Class II.

The affected units were distributed worldwide, including the United States, Italy, the UK, Finland, Germany, Ireland, and Turkey. Specific batch numbers for each reference number are listed in the official recall documentation. Healthcare providers and facilities should check their inventory for these specific reference and batch numbers and stop using the affected products immediately.

The recalled product

Product
bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other
Manufacturer
Beaver-Visitec International Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
526,220

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 378235
  • Batch Numbers: 3182650 3199216 3208791 3219552

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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