Dragonfly Laryngeal Electrode Recalled Due to Sterilization Process Issues
Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization parameters. The affected lots are LS20E2538I and 110320C, distributed to select US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: No illnesses or injuries are reported. The recall concerns possible sterilization deviations in an FDA Class II medical device, which constitutes a risk-of-harm product without reported injury.
Plain-English summary
Spes Medica is recalling the Dragonfly Laryngeal Surface Electrode (ET tube size 6.0-7.5 mm, reference numbers LSE3463DCA200 and LSE500DCS-5), which is used for continuous electromyography (EMG) monitoring of the larynx during surgical procedures. The recall affects 8 boxes of product.
The supplier informed the manufacturer of possible deviations in the parameters and processes used for ethylene oxide sterilization. Proper sterilization is essential for medical devices that are used internally during surgical procedures.
The affected product was distributed to medical facilities in California, Massachusetts, and South Carolina under lot numbers LS20E2538I and 110320C.
Healthcare providers and facilities receiving this product should contact Spes Medica for instructions regarding the recalled devices.
The recalled product
- Product
- 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.
- Manufacturer
- Spes Medica
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot LS20E2538I and 110320C
Distribution
Part of a larger recall action
This product is one of 5 recalled by Spes Medica under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Spes Medica
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