Waltham, MA, United States
Beaver-Visitec International Inc. recalls
4 recalls recorded since 2018, most recently on 5 December 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 December 2025
- Reason
- 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
- US Nationwide distribution in the states of FL, MI, OK, TX, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1008-2026
- BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Terminated Class II Medical devices
- Recall started
- 26 February 2018
- Terminated
- 30 October 2019
- Reason
- Products were packaged with incorrect labeling,
- Distribution
- US Nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1801-2018
- Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549
Terminated Class II Medical devices
- Recall started
- 26 February 2018
- Terminated
- 28 January 2019
- Reason
- Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
- Distribution
- Distributed to the states of OH, NY, FL, MN, and KS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1539-2018
- WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
Terminated Class II Medical devices
- Recall started
- 3 November 2017
- Terminated
- 31 May 2023
- Reason
- The protective shield was retracted, and the blade was exposed.
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0500-2018, Z-0501-2018, Z-0503-2018, Z-0504-2018, Z-0502-2018
- 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,
- 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
- bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
- 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 u
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.