The Recall Desk
HighFDA (Devices)·Z-0502-2018·Announced 2018-02-07

Beaver Xstar Safety Slit Knives Recalled Due to Retracted Protective Shield

Beaver-Visitec International Inc. is recalling 659,370 units of bvi Beaver Xstar Safety Slit Knives because the protective shield was retracted, exposing the blade.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 the hazard involves a sharp surgical instrument with an exposed blade, which poses a risk of harm (injury) even though specific injury reports are not detailed in the provided text.

Plain-English summary

Beaver-Visitec International Inc. is recalling 659,370 units of bvi Beaver Xstar Safety Slit Knives. The recall involves multiple reference numbers and batch numbers, including REF 378214 through REF 378232, REF 378822 through REF 378832, REF 370145, REF 370146, REF 373025, and REF 373032. These specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT, and other surgical applications.

The reason for the recall is that the protective shield was retracted, and the blade was exposed. This defect presents a risk of injury to users during surgical procedures. The affected products were distributed worldwide, including in the United States, Italy, the UK, Finland, Germany, Ireland, and Turkey.

Healthcare facilities and users should stop using the affected knives immediately. They should check their inventory against the specific reference and batch numbers listed in the official recall notice. Users should contact Beaver-Visitec International Inc. for instructions on how to return or dispose of the affected units.

The recalled product

Product
bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2
Manufacturer
Beaver-Visitec International Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
659,370

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 (9)

  • (a) REF 378214
  • Batch numbers: 3179722 3185257 3213020 (b) REF 378215
  • Batch numbers: 3198433 3210262 3219547 (c) REF 378217
  • Batch numbers: 3182674 3211158 3216039 (d) REF 378218
  • Batch numbers: 3191985 3204382 3225442 (h) REF 378224
  • Batch numbers: 3202917 3209398 3213734 3218192 3224262 (m) REF 378822
  • Batch numbers: 3198295 3217382 3219643 3223116 (u) REF 378832
  • Batch numbers: 3180337 3199934 3216477 (v) REF 370145
  • Batch numbers: 3180597 3204042 3206983 3216349 3222360 3223823

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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