RegulatorsFDAUnited States
Covidien MonaTherm General Purpose Temperature Probe Recall (Class 2)
Regulatory action
Recall
Shiley Cuffed Fenestrated Adult Tracheostomy Tube · Covidien (Medtronic)
Lot/batch: Z-2261-2026
Relevant for
Regulatory Intelligence LeadSignal Management Lead
Action needed
Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.
Process impact
Signal ManagementLabeling
SOP impact
2 SOPs may need review
Urgency: HighConfidence: high
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