Changeflow GovPing Healthcare & Life Sciences SureForm 30 8mm Surgical Stapler Recall
Urgent Enforcement Removed Final

SureForm 30 8mm Surgical Stapler Recall

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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.

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

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

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

Archived snapshot

Mar 30, 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° 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)

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Last updated

Classification

Agency
ANSM
Filed
March 30th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2607062
Docket
R2607062

Who this affects

Applies to
Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Recall
Geographic scope
France FR

Taxonomy

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

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