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Urgent Enforcement Added Final

Recall of Dental Root Canal Instruments - Shenzhen Perfect Medical

Favicon for ansm.sante.fr ANSM Drug & Device Safety Alerts
Filed March 31st, 2026
Detected March 31st, 2026
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Summary

ANSM issued safety recall R2606807 for dental root canal instruments manufactured by Shenzhen Perfect Medical Instruments Co., Ltd. The recall involves a lot withdrawal due to identified safety concerns. Healthcare facilities, dentists, and medical professionals using these instruments must identify and remove affected products from use.

What changed

ANSM has recorded safety action R2606807 concerning a lot withdrawal of dental root canal instruments from Shenzhen Perfect Medical Instruments Co., Ltd. The recall was initiated after quality or safety issues were identified with the products. The affected users received direct notification from the manufacturer with the recall letter dated 31/03/2026.

Healthcare providers, dental surgeons, and medical facilities must immediately identify any dental root canal instruments from Shenzhen Perfect Medical in their inventory and remove affected products from use. Distributors and suppliers of these instruments should coordinate with the manufacturer to ensure proper recall execution. Users with questions should contact Shenzhen Perfect Medical Instruments Co., Ltd directly as indicated in the recall correspondence.

What to do next

  1. Identify dental root canal instruments from Shenzhen Perfect Medical Instruments Co., Ltd in your inventory
  2. Remove all affected instruments from use immediately
  3. Contact the manufacturer for return instructions and follow lot-specific recall procedures

Source document (simplified)

A+ A-

Rappel n° R2606807 destiné aux établissements de santé, médecins, chirurgiens-dentistes L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Shenzhen Perfect Medical Instruments Co., Ltd.
Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2606807.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Shenzhen Perfect Medical Instruments Co., Ltd (31/03/2026)

Source

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

Classification

Agency
ANSM
Filed
March 31st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2606807

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Recall Dental Instrument Distribution
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Product Safety Healthcare

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