# FDA recall Z-1967-2021

> **Spes Medica** · Class II · device recall initiated 2021-04-08.

## Product

Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1, Reference Numbers LSE4246MCA075 and LSE500M.  for continuous EMG monitoring of the larynx during surgical procedures.

## Reason for recall

The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

## Distribution

Distribution in the following US states: CA, MA, and SC.

## Key facts

- **Recall number:** Z-1967-2021
- **Recalling firm:** Spes Medica
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-08
- **Report date:** 2021-07-07
- **Termination date:** 2022-05-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Genoa, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1967-2021

## Citation

> AI Analytics. FDA recall Z-1967-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1967-2021. Source: US FDA. Licensed CC0.

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