Dragonfly Laryngeal Surface Electrode recalled for sterilization process deviation
Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization process. Affected lot LS20G3274I was distributed in California, Massachusetts, and South Carolina.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device with a sterilization process deviation. No illnesses or injuries have been reported, and the hazard remains theoretical. The source text explicitly states no reported adverse events, placing the maximum score at 3 per the rubric. The precautionary nature of the recall and lack of confirmed contamination warrant a score of 2.
Plain-English summary
Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes (Reference Numbers LSE4246MCA075 and LSE500M), which are used for continuous EMG monitoring of the larynx during surgical procedures. The recall affects Lot LS20G3274I, which consists of 20 boxes distributed in California, Massachusetts, and South Carolina.
The supplier informed Spes Medica of possible deviations in the parameters and processes used for ethylene oxide sterilization of these devices. Proper sterilization is critical to ensure the safety and functionality of medical devices used in surgical procedures.
Healthcare facilities that received this lot should identify any remaining devices from Lot LS20G3274I and stop using them immediately. Facilities should contact Spes Medica for instructions regarding return or replacement of affected units. For additional information, please reference FDA recall number Z-1967-2021.
The recalled product
- 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.
- Manufacturer
- Spes Medica
- Affected units
- 20
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 LS20G3274I
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
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