# FDA recall Z-0501-2018

> **Beaver-Visitec International Inc.** · Class II · device recall initiated 2017-11-03.

## Product

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 and other surgical applications.

## Reason for recall

The protective shield was retracted, and the blade was exposed.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

## Key facts

- **Recall number:** Z-0501-2018
- **Recalling firm:** Beaver-Visitec International Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-03
- **Report date:** 2018-02-07
- **Termination date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2018

## Citation

> AI Analytics. FDA recall Z-0501-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0501-2018. Source: US FDA. Licensed CC0.

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