CLASS II Device recall · Reported 7 Jul 2021 · FDA Enforcement Report
Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm) recalled
Spes Medica is recalling Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 0-7.5, Channel 2, Reference, distributed in California, Massachusetts, South Carolina. The recall was initiated on 8 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1969-2021
- FDA event ID
- 87999
- Recalling firm
- Spes Medica, Genoa, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2021
- FDA classified
- 25 Jun 2021
- Reported
- 7 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 8 Apr 2021 | Recall initiated by company | |
| 25 Jun 2021 | Classified by FDA | +78 days |
| 7 Jul 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Distribution in the following US states: CA, MA, and SC.
Questions about this recall
Is Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 0-7.5, Channel 2, Reference recalled?
Yes. Spes Medica recalled Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 0-7.5, Channel 2, Reference on 8 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1969-2021.
Why was it recalled?
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Which lots are affected?
Lot LS20E2538I and 110320C
Where was it sold?
Distribution in the following US states: CA, MA, and SC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Spes Medica
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SNS Disposable Urethral Catheter Electrode recalled by Spes Medica | Spes Medica | Lead & Heavy Metals | CA, MA, SC |
| Device | CLASS II | Tripolar Hooked Stimulation Probes, L= recalled by Spes Medica | Spes Medica | Sterility | CA, MA, SC |
| Device | CLASS II | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm) recalled | Spes Medica | Sterility | CA, MA, SC |
| Device | CLASS II | SNS Disposable Urethral Catheter Electrode recalled by Spes Medica | Spes Medica | Lead & Heavy Metals | CA, MA, SC |
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| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |