# FDA recall Z-1155-2021

> **Bovie Medical Corporation** · Class II · device recall initiated 2021-02-01.

## Product

ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

## Reason for recall

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

## Distribution

US Nationwide distribution in the states of CA and FL.

## Key facts

- **Recall number:** Z-1155-2021
- **Recalling firm:** Bovie Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-01
- **Report date:** 2021-03-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Clearwater, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1155-2021

## Citation

> AI Analytics. FDA recall Z-1155-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1155-2021. Source: US FDA. Licensed CC0.

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