Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1967-2021 — 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.

U.S. FDA — Device Enforcement · Italy · 2021-04-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1967-2021
Date of alert
2021-04-08
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
Spes Medica
Product category
device
Product type
Devices
Reported risk: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.