Changeflow GovPing Pharma & Drug Safety Physio-Control/Stryker France DAE Electrode Kit...
Urgent Enforcement Amended Final

Physio-Control/Stryker France DAE Electrode Kit Recall - Infant/Child Use

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Summary

ANSM reports a safety recall by Physio-Control/Stryker France SAS for infant and child DAE (automated external defibrillator) electrode kits. Reference numbers R2607604/R2610482. Affected lots expired between August 2025 and January 2026. Hospital pharmacies, distributors, and operators holding these products should contact Stryker France directly for guidance.

Published by ANSM on ansm.sante.fr . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

Physio-Control/Stryker France SAS has initiated a product recall for infant and child DAE electrode kits under ANSM reference R2607604/R2610482. Affected lots expired between August 2025 and January 2026. The manufacturer has issued a direct communication to affected parties.\n\nHospital pharmacies, distributors, and healthcare facility operators should immediately verify whether they hold affected lots and contact Stryker France directly for instructions. ANSM has recorded this safety action and directs all inquiries to the manufacturer.

What to do next

  1. Contact Stryker France SAS directly for return and replacement instructions
  2. Verify if your facility holds affected lots (R2607604/R2610482)

Archived snapshot

Apr 13, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Rappel n° R2607604/R2610482 destiné aux pharmacies d'usage intérieur, distributeurs et exploitants L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Physio-Control, Inc./Stryker France SAS. Les lots concernés ont expiré entre août 2025 et janvier 2026.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607604/R2610482. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Stryker France SAS (13/04/2026)

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Last updated

Classification

Agency
ANSM
Filed
April 13th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2607604/R2610482

Who this affects

Applies to
Healthcare providers Distributors
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall Product safety response
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Public Health

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