ANSM Safety Alert: Radius VSM ECG Electrodes and Blood Pressure Cuffs

Detected March 25th, 2026

Summary

The French ANSM has issued a safety alert regarding a lot recall of Radius VSM ECG electrodes and blood pressure cuffs by Masimo Corporation. This action is registered under recall number R2607611 and is directed at pharmacies and healthcare facilities.

View original document View source feed page

What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert concerning a lot recall of Radius VSM ECG electrodes and blood pressure cuffs manufactured by Masimo Corporation. The recall, registered under number R2607611, affects specific batches of these medical devices. The alert is directed towards pharmacies, internal hospital pharmacies, and outpatient healthcare facilities.

Healthcare providers in possession of the affected lots should be aware of this recall and follow the instructions provided by Masimo Corporation, as detailed in the company's letter dated March 25, 2026. For any inquiries, users are advised to contact Masimo Corporation directly. This action highlights the importance of vigilance in medical device safety and adherence to recall procedures.

What to do next

Identify and quarantine affected Radius VSM ECG electrodes and blood pressure cuffs.
Follow instructions provided by Masimo Corporation for lot return or disposal.
Consult Masimo Corporation directly for any questions regarding the recall.

Source document (simplified)

A+ A-

Rappel n° R2607611 destiné aux pharmacies d'usage intérieur, officines et structures de soins de ville L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Masimo Corporation.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607611. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Masimo Corporation (25/03/2026)