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Priority review Enforcement Added Final

Getinge Steam Sterilizer Safety Recall for Pre-September 2019 Devices

Favicon for ansm.sante.fr ANSM Drug & Device Safety Alerts
Filed April 2nd, 2026
Detected April 2nd, 2026
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Summary

ANSM has recorded a safety action (R2609375) initiated by Getinge Sterilization AB regarding steam sterilizers manufactured before September 4, 2019. Healthcare facilities using affected devices have received a manufacturer letter with safety instructions. This recall targets hospital pharmacies, health establishments, and city care structures in France.

What changed

Getinge Sterilization AB has initiated a safety action for steam sterilizers manufactured prior to September 4, 2019. ANSM has recorded this recall under reference number R2609375. Affected devices have been identified through manufacturer records, and users have received direct notification from Getinge.

Healthcare facilities with affected sterilizers must review the manufacturer letter received and follow the provided safety instructions. Operators should verify whether their equipment falls within the affected manufacturing window and take recommended corrective actions. Non-compliance with recall procedures could result in regulatory sanctions and continued patient safety risks.

What to do next

  1. Identify any Getinge steam sterilizers manufactured before September 4, 2019 in your facility
  2. Review the manufacturer letter from Getinge Sterilization AB (dated 02/04/2026)
  3. Implement the safety measures specified in the Getinge correspondence

Source document (simplified)

A+ A-

Information n° R2609375 destinée aux pharmacies d'usage intérieur, établissements de santé, structures de soins de ville L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Getinge Sterilization AB.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2609375.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Getinge Sterilization AB (02/04/2026)

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
ANSM
Filed
April 2nd, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2609375

Who this affects

Applies to
Healthcare providers Medical device makers Patients
Industry sector
6211 Healthcare Providers 3345 Medical Device Manufacturing
Activity scope
Medical Device Safety Healthcare Equipment Maintenance
Threshold
Steam sterilizers manufactured before September 4, 2019
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Topics
Healthcare Product Safety

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