Olympus Thunderbeat II Medical Device Recall
Summary
ANSM issued safety alert R2608456 regarding a lot withdrawal of Olympus Thunderbeat II ultrasonic and electric surgical scissors. Olympus notified the agency of a batch recall affecting interior use pharmacies and health establishments in France. Users received direct correspondence with recall instructions. The recall is registered under reference R2608456.
What changed
Olympus initiated a lot-specific withdrawal of Thunderbeat II ultrasonic and electric surgical scissors (bistouri à ultrason et électrique ciseaux) under ANSM reference R2608456. The recall notice targets pharmacies d'usage intérieur (hospital pharmacies) and health establishments. Users received the manufacturer's letter dated 03/04/2026 with specific recall instructions.
Healthcare facilities must immediately identify affected Thunderbeat II devices in their inventory, distribute the Olympus recall communication to relevant clinical staff, and coordinate device return or replacement. Non-compliance with medical device recall procedures may result in regulatory sanctions and potential liability for patient safety incidents.
What to do next
- Identify and quarantine all Thunderbeat II devices matching the recalled lot numbers
- Distribute the Olympus recall letter to affected clinical departments and surgical staff
- Coordinate device return or replacement with Olympus per the manufacturer instructions
Source document (simplified)
Rappel n° R2608456 destiné aux pharmacies d'usage intérieur et établissements de santé L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectuée par la société Olympus.
Les utilisateurs concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2608456. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Olympus (03/04/2026)
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