# FDA recall Z-1111-2019

> **Beaver Visitec** · Class II · device recall initiated 2019-03-12.

## Product

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel,  Ophthalmic-utilized in Cataract and Glaucoma procedures  REF # 370824    Product Usage:  Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

## Reason for recall

Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device

## Distribution

Worldwide Distribution - US Nationwide  Foreign:UNITED KINGDOM  JAPAN  NETHERLANDS

## Key facts

- **Recall number:** Z-1111-2019
- **Recalling firm:** Beaver Visitec
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-12
- **Report date:** 2019-04-17
- **Termination date:** 2020-08-11

- **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-1111-2019

## Citation

> AI Analytics. FDA recall Z-1111-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1111-2019. Source: US FDA. Licensed CC0.

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