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publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 8, 2026

Class 4 Defect Notification: Cadila Mirtazapine 30mg Tablets (EL(26)A/28)

Urgency: High

Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medicines Defect Notification (Class 4)
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publicSwissmedic · Switzerland · Updated Jun 5, 2026

Urgent Field Safety Notice (RECALL) - One-Piece Guedel Airways

Urgency: High

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Field Safety Notice / Recall
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publicFDA · USA · Updated Jun 5, 2026

GE HealthCare Carestation Devices - Correction for Ineffective Ventilation in VCV Mode (FDA Class I Recall)

Urgency: High

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medical Device Recall / Correction
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publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 5, 2026

EMA Updates Acceptable Intake Levels for Nitrosamine Impurities in Human Medicines

Urgency: High

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Regulatory Update
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publicFDA · USA · Updated Jun 5, 2026

GE HealthCare Infant Resuscitation System Air-Oxygen Blender Issue

Urgency: High

Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Early Alert
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publicTGA · Australia · Updated Jun 5, 2026

TGA Safety Alert: FluMist Indicated Age Range Errors

Urgency: High

Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 5, 2026

Cosyland Kids Kitchen Step Stools recalled due to fall and entrapment hazards (Model CS0003)

Urgency: High

Immediately stop using the recalled stools, store away from children, and contact Wan Yi (866-677-3889 / customerservice-ca@cosyland.com) to request free repair parts (protective nets, stabilizing feet, instructions).

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Consumer product recall
Read impact briefarrow_forward
publicEuropean Medicines Agency (EMA) · European Union · Updated Jun 5, 2026

Ixchiq (Chikungunya vaccine (live)) - Safety measures following PRAC review

Urgency: High

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: PRAC recommendation
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publicHealth Canada · Canada · Updated Jun 4, 2026

ARTIS Icono Ceiling, Floor and Biplane Systems Recall

Urgency: High

Identify and quarantine affected ARTIS Icono systems in inventory; contact manufacturer for update guidance.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Health Product Recall
Read impact briefarrow_forward
publicTGA · Australia · Updated Jun 4, 2026

Unapproved ibutamoren capsules (MK-677) found to contain undisclosed anabolic steroid

Urgency: High

Consumers must stop taking the product immediately and return remaining capsules to a pharmacy for safe disposal.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicFDA · USA · Updated Jun 4, 2026

FDA Safety Labeling Change Order for ADZYNMA

Urgency: High

Review the specific labeling changes required by the FDA order and update internal safety documents and signal evaluation for ADZYNMA accordingly.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Labeling Change Order
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publicHSA · Singapore · Updated Jun 4, 2026

HeartWare Ventricular Assist System Batteries - HSA Field Safety Notice

Urgency: High

Identify and quarantine affected HeartWare batteries; follow manufacturer's instructions for battery management and replacement; ensure patients and healthcare providers are informed.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Field Safety Notice
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 4, 2026

Giraffe™ OmniBed™ Carestation™ - Fastener Disengagement Risk

Urgency: High

Healthcare facilities should implement manufacturer's corrective actions to ensure safe operation.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medical Device Recall
Read impact briefarrow_forward
publicHSA · Singapore · Updated Jun 4, 2026

Urgent Field Action Notification of Advanced Bionics HiRes Ultra / Ultra 3D

Urgency: High

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Urgent Field Action
Read impact briefarrow_forward
publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 4, 2026

Pharmatech MK-677 Capsules: Undisclosed Anabolic Steroid Found

Urgency: High

Stop using and dispose of Pharmatech MK-677 capsules immediately; consult a healthcare professional if concerned.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Safety Alert
Read impact briefarrow_forward
publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 4, 2026

Recall: Nature's Own Glucosamine Sulfate with Chondroitin and Magnesium Glycinate 1150mg

Urgency: High

Stop using affected batches; return to place of purchase for full refund.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Recall
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 4, 2026

Wyze Solar Cam Pan Recalled Due to Burn and Fire Hazards

Urgency: High

Immediately stop use; visit Wyze Labs website for refund process. Report incidents to Health Canada.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Consumer product recall
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 3, 2026

Dexcom G7 Sensor Lot Recall – Unauthorized Distribution of Non-Conforming Lots in Canada

Urgency: High

Identify and quarantine products from lots 1725204004 and 1725069002; contact patients who received sensors from these lots; report adverse events if any.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medical Device Recall
Read impact briefarrow_forward
publicTGA · Australia · Updated Jun 3, 2026

Nature's Own Glucosamine Sulfate with Chondroitin and Nature's Own Magnesium Glycinate 1150mg Recall by Sanofi Consumer Healthcare

Urgency: High

Return recalled products to place of purchase for refund or contact Customer Care for return arrangements.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Recall
Read impact briefarrow_forward
publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 2, 2026

MHRA Class 2 Recall: ChloraPrep 2% applicators (potential sterility breach)

Urgency: High

Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Class 2 Medicines Recall
Read impact briefarrow_forward
publicHealth Canada · Canada · Updated Jun 1, 2026

Omnipod Insulin Management System Recall in Canada

Urgency: High

Identify affected lots and implement recall procedures as per Health Canada guidelines.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Health product recall
Read impact briefarrow_forward
publicFood and Drug Administration (FDA) · USA · Updated May 29, 2026

Covidien MonaTherm General Purpose Temperature Probe Recall (Class 2)

Urgency: High

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

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Class 2 Device Recall
Read impact briefarrow_forward
publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated May 29, 2026

MHRA Largest Seizure of Unlicensed Weight Loss Medicines

Urgency: High

Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Enforcement Action / Public Safety Alert
Read impact briefarrow_forward
publicFDA · United States · Updated May 29, 2026

FDA Public Notification: Tawon Liar Contains Hidden Drug Ingredients

Urgency: High

Review product inventory for Tawon Liar; report any adverse events to FDA MedWatch; consider adding product to signal monitoring list; ensure labeling compliance checks for similar products.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Public Notification
Read impact briefarrow_forward
publicEMA · European Union · Updated Jun 5, 2026

Calcifediol PSUSA: Maintenance of Marketing Authorisation (PSUSA/00000491/202506)

Monitoring

Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: PSUSA
Read impact briefarrow_forward
publicMedicines and Healthcare products Regulatory Agency (MHRA) · United Kingdom · Updated Jun 4, 2026

Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe

Monitoring

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Medicines recall/notification
Read impact briefarrow_forward
publicEuropean Medicines Agency (EMA) · European Union · Updated May 29, 2026

EMA ETF recommends updating COVID-19 vaccines to target XFG variant for 2026/2027 campaign

Monitoring

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Regulatory Recommendation / Public Health Communication
Read impact briefarrow_forward

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