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ANSM Drug & Device Safety Alert: Endoscopic Clip Device

Favicon for ansm.sante.fr ANSM Drug & Device Safety Alerts
Published May 20th, 2025
Detected March 17th, 2026
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Summary

The French ANSM has issued a safety information notice regarding a recall of specific lots of the Instinct Plus endoscopic clip device by Wilson-Cook Medical, Inc. This action follows a previous safety alert and is registered under ANSM reference R2606331.

What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety information notice (R2606331) concerning a lot recall for the Instinct Plus endoscopic clip device manufactured by Wilson-Cook Medical, Inc. This recall is a follow-up to a previous safety alert (R2512885) dated May 20, 2025, and involves specific lots of the device. The notice directs concerned users to contact the manufacturer directly for further information and provides a link to the manufacturer's letter dated March 17, 2026.

Healthcare providers, particularly pharmacies within health establishments, are the primary audience for this notice. While no specific compliance deadline is mentioned, affected entities should review the manufacturer's communication and ensure appropriate actions are taken regarding the recalled lots. The ANSM emphasizes directing questions to the manufacturer, Wilson Cook Medical Inc., indicating that direct engagement with the company is the required next step for clarification and resolution.

What to do next

  1. Review safety information notice R2606331 from ANSM.
  2. Consult the manufacturer's letter dated March 17, 2026, regarding the recalled lots of Instinct Plus endoscopic clip devices.
  3. Contact Wilson-Cook Medical, Inc. directly for any questions or to confirm actions taken on recalled lots.

Source document (simplified)

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Information n° R2606331 destinée aux pharmacies à usage intérieur des établissements de santé L'ANSM a été informée de la mise en œuvre d’un rappel de lots effectué par la société Wilson-Cook Medical, Inc.  Cette action fait suite à l’information de sécurité diffusée le 20/05/2025 (Référence ANSM : R2512885).

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2606331.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Wilson Cook Medical Inc (17/03/2026) INFORMATION AUX UTILISATEURS Dispositifs médicaux Publié le 20/05/2025 ##### Pince à clip – Dispositif de pose endoscopique de clips Instinct Plus – Wilson-Cook Medical, Inc.

Information de sécurité n° R2512885 destinée aux pharmacies d'usage intérieur

Source

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

Classification

Agency
ANSM
Published
May 20th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers
Geographic scope
France

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Medical Devices Product Safety

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