SureForm 30 8mm Surgical Stapler Recall

ANSM Drug & Device Safety Alerts

Filed March 30th, 2026

Detected March 30th, 2026

Summary

ANSM issued safety alert R2607062 regarding Intuitive Surgical's voluntary recall of SureForm 30 8mm Gray Reload surgical stapler devices. The recall affects hospital pharmacies and surgical departments using computer-assisted surgery systems. Healthcare facilities must identify and remove affected devices from use.

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What changed

Intuitive Surgical initiated a product withdrawal for the SureForm 30 8mm Gray Reload (recharge grise) used with the SureForm 30 8mm stapler in computer-assisted surgery. The recall is registered with ANSM under reference number R2607062. This action affects all hospital pharmacies and healthcare facilities that stock or use these specific reload cartridges.

Hospital pharmacy managers and surgical department heads should immediately review inventory for affected SureForm 30 8mm reloads, download the manufacturer letter from March 30, 2026, and follow Intuitive Surgical's instructions for returning the recalled products. Compliance with recall procedures is required to prevent use of potentially defective surgical stapling components.

What to do next

Identify all SureForm 30 8mm Gray Reload units in hospital inventory
Download and review Intuitive Surgical's recall letter dated 30/03/2026
Remove affected devices from use and follow manufacturer's return instructions

Source document (simplified)

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Rappel n° R2607062 destiné aux pharmacies d'usage intérieur des établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de retrait de produit effectuée par la société Intuitive Surgical.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607062. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Intuitive Surgical (30/03/2026)