Home / Recalls / Beaver-Visitec International Inc. / Z-0500-2018

Z-0500-2018 Class II Terminated

Recalled by Beaver-Visitec International Inc. — Waltham, MA

Recall Details

Product Type
Devices
Report Date
February 7, 2018
Initiation Date
November 3, 2017
Termination Date
May 31, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45, 680 units

Product Description

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.

Reason for Recall

The protective shield was retracted, and the blade was exposed.

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey

Code Information

(a) REF 370531; Batch numbers: 3185248 3191981 3193837 3199247 3201734 3204737 3206382 3208096 3211720 3213361 3214546 3217371 3219431 3222626 3225976 (b) REF 378233; Batch numbers: 3191985 3204382 3225442

Other recalls by Beaver-Visitec International Inc.

  • Z-1008-2026 Class II — BVI Leos Laser and Endoscopy System. Model Number: OME6000U. (December 5, 2025)
  • Z-1539-2018 Class II — WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. (February 26, 2018)
  • Z-1801-2018 Class II — Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 2 (February 26, 2018)
  • Z-0501-2018 Class II — bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, R (November 3, 2017)
  • Z-0504-2018 Class II — bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) S (November 3, 2017)
  • Z-0502-2018 Class II — bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) (November 3, 2017)
  • Z-0503-2018 Class II — bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product U (November 3, 2017)
  • Z-1803-2015 Class II — BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove (May 1, 2015)
  • Z-1802-2015 Class II — BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove (May 1, 2015)
  • Z-1804-2015 Class II — BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove (May 1, 2015)