# FDA recall Z-1497-2023

> **Beaver Visitec International, Inc.** · Class II · device recall initiated 2023-03-17.

## Product

CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue.    Ref: CT00.D01

## Reason for recall

Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1497-2023
- **Recalling firm:** Beaver Visitec International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-17
- **Report date:** 2023-05-10

- **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-1497-2023

## Citation

> AI Analytics. FDA recall Z-1497-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1497-2023. Source: US FDA. Licensed CC0.

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