PV Bulletin

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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm

PV Impact Brief

Urgency: HighConfidence: high

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.

Action needed

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

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

single event

Regulatory action details

Action type
Class 2 Device Recall
Publication date
2026-06-04
Safety issue
The system may sporadically display a 0 x-ray dose administered to the patient during fluoroscopy and/or single-frame acquisitions, even though an actual x-ray dose is being applied.

Affected products

  • ARTIS pheno interventional fluoroscopic x-ray system
    Siemens Medical Solutions USA, Inc

PV internal implications

Distribution of Customer Advisory Notice (CAN) to all affected customers.

View regulator source

Evidence and confidence

Confidence: highSource updated: May 29, 2026

Full briefing

Practical implication

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

The FDA announced a Class 2 recall by Covidien (Medtronic) for MonaTherm General Purpose Temperature Probe, lot Z-2273-2026. Users must quarantine and return unused products.

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.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

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

Related updates for your role

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Urgency: High

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Urgency: High

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Urgency: High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward