Spes Medica: Medical Device Recall in 2021 - (Recall #: Z-1969-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.

Product Classification:

Class II

Date Initiated: April 8, 2021

Date Posted: July 7, 2021

Recall Number: Z-1969-2021

Event ID: 87999

Reason for Recall:

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

Status: Terminated

Product Quantity: 8 boxes

Code Information:

Lot LS20E2538I and 110320C

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated