# FDA recall Z-2240-2021

> **Covidien Llc** · Class II · device recall initiated 2021-06-23.

## Product

Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade.   Product Number: SCGAA

## Reason for recall

Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located

## Distribution

US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and   WA.

## Key facts

- **Recall number:** Z-2240-2021
- **Recalling firm:** Covidien Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-23
- **Report date:** 2021-08-18
- **Termination date:** 2025-01-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2240-2021

## Citation

> AI Analytics. FDA recall Z-2240-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-2240-2021. Source: US FDA. Licensed CC0.

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