Home / Recalls / Beaver-Visitec International, Inc. / Z-1008-2026

Z-1008-2026 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
January 7, 2026
Initiation Date
December 5, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

Product Description

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Reason for Recall

Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).

Distribution Pattern

US Nationwide distribution in the states of FL, MI, OK, TX, WI.

Code Information

Model Number: OME6000U. UDI: (01)00886158037576(11)250513(21). Serial Numbers: 77UBV500003, 77UBV500004, 77UBV500005, 77UBV500006, 77UBV500010.

Other recalls by Beaver-Visitec International, Inc.

  • 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-0500-2018 Class II — bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) (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)