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RegulatorsFDAUSA

Covidien MonaTherm General Purpose Temperature Probe Recall (Class 2)

Covidien (Medtronic) recalls specific lots of MonaTherm probes due to potential incorrect temperature readings or quality defects.

PV Impact Brief

Urgency: HighConfidence: high
Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Action needed

Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.

Owner

Regulatory Intelligence Lead

Review cadence

single event

Regulatory action details

Action type
Class 2 Device Recall
Publication date
2026-06-01
Safety issue
Recall involving software release issues with the Roadmap Pro Software key on Azurion 5M12 systems.

Affected products

  • Philips Azurion 5M12
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

View regulator source

Evidence and confidence

Confidence: highSource updated: May 29, 2026

Full briefing

What changed

FDA classified the Covidien MonaTherm probe recall as Class 2 and instructed users to quarantine and return unused products.

Why it matters

Incorrect temperature readings could lead to misdiagnosis or inappropriate patient management, posing serious safety risks.

Practical implication

Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.

#Safety Signals#Recall#FDA#safety_signal#firecrawl-agent#regulatory-extraction

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