ANSM Drug & Device Safety Alerts

Philips MRI Elastography Safety Information R2611182

ANSM has recorded a field safety corrective action by Philips affecting MRI systems with magnetic resonance elastography (MRE) installed at healthcare facilities and medical imaging centers. The action is registered under reference R2611182. Affected users have received direct communication from Philips containing the specific safety instructions and required actions. ANSM directs all enquiries regarding this safety action to Philips as the issuing party.

Cardiac Cryoablation Device Recall - Boston Scientific Polarx System Safety Alert R2610453

ANSM has recorded safety alert R2610453 following Boston Scientific's recommendation to stop use and recall of its Polarx and Polarx Fit cardiac cryoablation balloon catheters, PolarSheath steerable sheaths, and SmartFreeze cryoablation system consoles. Affected healthcare establishments have received direct notification from Boston Scientific. Users seeking further information are directed to contact Boston Scientific directly.

Hologic Mammographe RX 3Dimensions and Selenia Dimensions Safety Notice

ANSM (France) notified healthcare facilities of a safety action conducted by Hologic Inc. for Mammographe RX 3Dimensions and Selenia Dimensions mammography systems, registered under reference number R2609345. Affected users received a direct communication from the manufacturer with further details. This action involves medical imaging equipment used in breast cancer screening.

Olympus Gyrus ACMI Everest Cutting Forceps Lot Recall R2607996

ANSM registered safety action R2607996 concerning a lot withdrawal of Everest cutting forceps (pince coupante) manufactured by Olympus Gyrus ACMI. The recall was initiated by Olympus following notification to ANSM. Affected users received a direct communication from the manufacturer. This action targets hospital pharmacies and health establishments that hold the implicated lot.

MaaT013 Fecal Microbiota Allogeneic Pool Rectal Suspension Recall

ANSM and Clinigen Healthcare France have initiated a precautionary recall of six lots of MaaT013 (fecal microbiota allogeneic pool, rectal suspension). The recall follows discovery of a donor selection process non-compliance where a donor meeting exclusion criteria was included in stool collections used to manufacture the affected lots. Healthcare establishments holding affected lots (7P010/2410111, 7P010/2410092, 7P010/2410096, 7P010/2410109, 7P010/2503009, 7P010/2503012) should quarantine and return product to the manufacturer.

Patch 4 Cover FSL Sim Tatoo Adhesive Patch Recall

ANSM recorded safety action R2611097 initiated by Capteur Protect for the Patch 4 Cover FSL Sim Tatoo adhesive patch used with glucose sensors. Users of affected products received notification letters from the company. The recall affects pharmacies, retail chains, and wholesale distributors in France.

Safety Notice Cryotubes Cryo.s Medical Devices by Greiner Bio-One

ANSM recorded safety action R2609958 concerning Cryotubes Cryo.s medical devices manufactured by Greiner Bio-One. The company has issued a safety communication dated 17/04/2026 to affected users. ANSM directs users to contact Greiner Bio-One directly for details and questions regarding the action.

Boston Scientific Accolade Pacemaker Safety Action - Software Update SMR6

ANSM has published updated safety information regarding Boston Scientific Accolade family implantable pacemakers (Accolade, Proponent, Essentio, Altrua 2, CRT-P Visionist, and Valitude). The agency reports that Boston Scientific is deploying software update SMR6 to correct anomalies in the previous SMR5 update and prevent inappropriate triggering of safety mode. For pace-dependent patients whose devices have not been updated with SMR5 and have 4 years or less of remaining battery life, an appointment should be scheduled without delay. SMR6 may reduce battery longevity for devices with extended longevity (EL) batteries. New device packaging since March 2026 includes information about potentially reduced battery life.

Safety Alert: Maintenance of CO2 Laser and VersaPulse PowerSuite DW Systems by Boston Scientific

ANSM registered safety action R2609352 regarding Boston Scientific's CO2 laser systems and dual-wavelength VersaPulse PowerSuite systems. Healthcare facilities using these laser devices have received a direct correspondence from Boston Scientific dated 16/04/2026 containing safety information. ANSM directs users with questions to contact Boston Scientific directly.

FH Ortho Biolox Delta Femoral Head Recall - ANSM Safety Alert R2610624

ANSM has recorded a lot withdrawal action by FH Ortho affecting Biolox Delta femoral heads used in hip prostheses. The safety action is registered as No. R2610624. Healthcare establishments that received the recall letter should contact FH Ortho directly with any questions.

Medtronic SynchroMed Implantable Pump Software Safety Alert for Health Establishments

ANSM has published a safety alert (Ref. R2610621) informing French healthcare establishments of a safety action taken by Medtronic Inc. regarding SynchroMed implantable pumps and associated software for the clinical programming tablet. Users have received a letter dated 16/04/2026 with details of the safety concern and recommended actions.

Aerys Medical Bed Half-Rails Safety Recall by Winncare France

ANSM has published a safety alert regarding a field safety corrective action (FSCA No. R2610462) conducted by Winncare France for Aerys and Aerys Confort sliding medical bed half-rails. Users of the affected products have received direct correspondence from Winncare France. The alert is directed to pharmacies, community care facilities, retail establishments, and home health service providers.

Intraocular Lens Podeye Safety Notice - Field Safety Notice R2610293

ANSM has informed health establishments of a safety action implemented by the company Physiol/BVI regarding Podeye intraocular lenses. The safety action is registered under reference number R2610293. Health establishments concerned by this action should review the attached letter from Physiol/BVI dated 14/04/2026.

Inova Diagnostics Aptiva CTD Essential Controls Safety Action

ANSM published safety alert R2608798 informing medical biology laboratories of a quality control recall by Inova Diagnostics for Aptiva CTD Essential Controls used in autoimmune testing. The manufacturer's safety action letter was distributed to affected users on 14 April 2026. Laboratories should review the recalled controls and contact Inova Diagnostics directly for guidance.

Physio-Control/Stryker France DAE Electrode Kit Recall - Infant/Child Use

ANSM reports a safety recall by Physio-Control/Stryker France SAS for infant and child DAE (automated external defibrillator) electrode kits. Reference numbers R2607604/R2610482. Affected lots expired between August 2025 and January 2026. Hospital pharmacies, distributors, and operators holding these products should contact Stryker France directly for guidance.

Da Vinci X Xi Cannula Screw Safety Notice - Intuitive Surgical

ANSM has published a safety notice (Reference R2606328) informing French healthcare facilities about a safety action by Intuitive Surgical regarding cannula support screws on da Vinci X and Xi robotic surgical systems. Users have received direct communication from the manufacturer. Healthcare facilities with these systems should review the attached manufacturer letter for specific guidance.

Anti-Lea Reagent Safety Alert - Diagast Immuno-Hematology

ANSM issued safety alert R2610123 regarding a security action taken by Diagast for its Anti-Lea Reagent (LE1) used in immuno-hematology testing. Medical biology laboratories using this diagnostic reagent must review the manufacturer's safety communication and take appropriate action. ANSM reference number R2610123.

Monnal TEO Ventilator Field Safety Corrective Action - Air Liquide Medical Systems

ANSM published a safety notice regarding field safety corrective action R2531145 for Air Liquide Medical Systems' Monnal TEO ventilator. The manufacturer issued updated safety correspondence dated 10 April 2026 superseding the November 2025 notification. Healthcare establishments using this resuscitation ventilator must review the corrective action requirements directly from the manufacturer.

DEX Ophthalmic Forceps Recall Katalyst Surgical Carl Zeiss Meditec

ANSM issued safety alert R2609552 informing French health establishments of a recall by Carl Zeiss Meditec for DEX ophthalmic forceps and scissors manufactured by Katalyst Surgical LLC. Affected health facilities must remove the devices from use and contact the manufacturer directly. The safety action letter was published April 9, 2026.

Recall Mycology Yeastone Broth 11ML Remel - R2609813

ANSM registered safety action R2609813 for Mycology Yeastone Broth 11ML Remel following a lot withdrawal initiated by Thermo Fisher. Medical biology laboratories that received the affected product have been notified directly by Thermo Fisher. This recall addresses a safety concern with specific lots of the reagent used in mycological testing.

Advanced Bionics Cochlear Implant Battery Compartment Recall, 847 Units

ANSM recorded a lot withdrawal by Advanced Bionics LLC for cochlear implant battery compartments (model ZN Air M CI-5501). The action, registered as R2609192, affects 847 units. Health establishments received direct notification from the company with instructions for identifying and returning affected devices.

Elekta Cervical/Intrauterine Brachytherapy System Safety Recall

ANSM published safety alert R2610148 informing healthcare facilities of a medical device safety action by Elekta regarding its cervical/intrauterine brachytherapy system. Users of affected devices have received direct notification from Elekta. The recall is effective April 9, 2026, and healthcare providers using this radiation therapy equipment must take immediate action.

Philips Azurion Interventional Radiology Recall, 847 Units

ANSM has recorded safety action R2603230 regarding Philips Azurion interventional radiology systems manufactured by Philips Medical Systems Nederland BV. Affected French healthcare facilities have received direct notification from Philips. The recall encompasses 847 units of the Azurion system. Healthcare providers should immediately review their inventory and contact Philips Medical Systems for corrective action.

Siemens Atellica CH CK_L Creatine Kinase Reagent Recall

ANSM has recorded a product recall by Siemens Healthcare Diagnostics for its Atellica CH Creatine Kinase (CK_L) biochemical reagent. The recall affects 847 units distributed to medical biology laboratories. This safety action is registered as ANSM reference number R2609472, with the manufacturer issuing recall correspondence on 07/04/2026.

Fresenius Dali 750 Kit Hemadsorption Device Safety Notice

ANSM issued a safety alert regarding a field safety corrective action conducted by Fresenius Medical Care AG for the Dali 750 Kit hemadsorption device. The safety action is registered under reference R2608923. Users of this medical device have received direct correspondence from Fresenius with details of the corrective measure.

IVascular Navitian Coronary Microcatheter Recall

ANSM issued a medical device safety recall (R2607706/R2609369) for IVascular Navitian coronary microcatheters manufactured by Life Vascular Device Biotech S.L. The recall affects specific lots and targets pharmacies and healthcare establishments in France. Users should immediately quarantine and return affected products following the manufacturer's instructions.

Adhese 2 Dental Amalgam Recall, Ivoclar Vivadent AG

ANSM issued safety alert R2609516 regarding a batch recall of Adhese 2 dental amalgam by Ivoclar Vivadent AG. Healthcare facilities, dental centers, and dental surgeons using this product should verify their inventory for affected lots. The company has directly notified impacted users with return instructions.

Olympus Thunderbeat II Medical Device Recall

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.

Vue PACS v12 Philips Medical Systems Safety Recall

ANSM reported a safety action by Philips Medical Systems Nederland BV regarding Vue PACS v12. Users have received direct notification from the manufacturer. The safety action is registered under reference R2607071.

Cair LGL 1mm Lateral Extension Set Recall

ANSM has mandated a recall of specific lots of Cair LGL 1mm lateral extension sets (Prolongateur Cair LGL 1mm latéral) at the agency's request. The manufacturer Cair LGL has implemented the lot withdrawal, and affected users have received notification letters dated 02/04/2026. The recall is registered under ANSM reference number R2607673.

Getinge Steam Sterilizer Safety Recall for Pre-September 2019 Devices

ANSM has recorded a safety action (R2609375) initiated by Getinge Sterilization AB regarding steam sterilizers manufactured before September 4, 2019. Healthcare facilities using affected devices have received a manufacturer letter with safety instructions. This recall targets hospital pharmacies, health establishments, and city care structures in France.

Cook Medical Product Recall - Multiple Medical Device References

ANSM issued a safety recall notice (Ref. R2607073) for multiple Cook Medical medical devices distributed in France. Affected products include Blue Rhino G2 tracheostomy kits (the only products distributed in France), central venous catheters, pleural drainage devices, NCompass biliary stone extractors, and CTO-12 micro wire guides. Users who received the affected products should have received direct notification from Cook Medical.

Maincare IC Prescription Module Safety Notice

ANSM issued a safety notice (n° R2609195) informing healthcare services that Maincare Solutions has implemented a security action on its IC prescription module software. Users of the affected software have received direct correspondence from the manufacturer regarding this action.

Inogen Rove 6 oxygen concentrator safety notice

ANSM has issued safety notice R2608138 informing three French home health providers about a field safety corrective action by manufacturer Inogen Inc. regarding the Inogen Rove 6 portable oxygen concentrator. The action was conducted directly by Inogen Inc., with ANSM acting as the notification authority. Providers should consult the attached manufacturer correspondence for specific safety instructions.

Mitomycine Substipharm 20 mg Filter Update for Injection Administration

ANSM issued an updated safety notice for Mitomycine Substipharm 20 mg, permanently including a Millex HV filter (0.45 μm / PVDF) with reconstitution vials. The agency clarified that filtration remains mandatory for intravenous, intra-arterial, and intra-serous administration but is no longer required for intravesical administration. Healthcare professionals in urology, oncology, and related specialties should update their administration protocols accordingly.

Ortho Vision Max Immuno-Hematology Device Safety Alert

ANSM issued a safety information notice (Ref. R2608831) regarding a safety action by QuidelOrtho for Ortho Vision Max and Ortho Vision automated immuno-hematology analyzers. Medical analysis laboratories using these devices have received direct correspondence from the manufacturer about the safety measure. Users with questions should contact QuidelOrtho directly.

Total Knee Replacement Tibial Insert Recall - Exatech Optetrak Logic

ANSM issued a safety alert (R2608390) regarding a lot recall for tibial inserts used in the Optetrak Logic total knee replacement system, manufactured by Exatech Inc. The recall affects hospital pharmacies and surgical centers using these devices. Healthcare facilities must identify and remove the affected lot from inventory.

Recall of Milestone Vacuum Bags - Burn Hazard

ANSM registered recall action R2607842 for Milestone vacuum bags manufactured by Microm Microtech. The recall was initiated due to burn hazard identified in affected products distributed to medical biology laboratories. Users have received notification letters with instructions for returning the recalled items.

Recall of Dental Root Canal Instruments - Shenzhen Perfect Medical

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.

Orbis Medication 3.x Safety Notice - DH Healthcare

ANSM informed healthcare facilities of a safety action (n° R2607882) implemented by DH Healthcare GmbH regarding Orbis Medication 3.x, a computer-aided prescribing software. Users have received direct correspondence from the manufacturer. Healthcare providers using this software should review the attached safety communication.

MarClamp Cut IQ Safety Notice - KLS Martin Group

ANSM issued safety notice R2608256 regarding KLS Martin Group's MarClamp Cut IQ electrosurgical device with instrument coding 23cm. Hospital pharmacies and healthcare establishments are directed to review and act upon the attached manufacturer safety communication. This is a Class I medical device safety action.

GE Healthcare Signa Premier MRI Safety Notice

ANSM informed health facilities and medical imaging centers of a safety action by GE Healthcare regarding the Signa Premier MRI system. The action is registered under reference R2608457. Healthcare providers who received the letter should review and implement the specified safety measures.

Recall of Veos-Kaphron Polyaxial Screwdrivers - Distimp Spinal Equipment

ANSM has issued safety alert R2608136 for a recall of 847 units of Veos-Kaphron polyaxial screwdrivers manufactured by Distimp. This spinal ancillary equipment recall is a mandatory action to remove potentially defective medical devices from use in healthcare facilities. All affected users have received direct notification from Distimp regarding the recall procedures.

Oxoid Salmonella 9-0 Recall - Remel/Thermo Fisher Scientific

ANSM issued safety notice R2608613 informing medical biology laboratories of a field safety corrective action by Remel/Thermo Fisher Scientific, involving the recall of 847 units of Oxoid Salmonella agglutinating sera (Salmonella 9-0). Affected users received a direct communication from Thermo Fisher Scientific with instructions. Laboratories should verify their inventory for affected lots and contact the manufacturer directly.

Safety alert Orbis Medication 3.x prescription software

Safety alert Orbis Medication 3.x prescription software

Philips Respironics Trilogy Evo Ventilator Safety Alert - Nebulizer Use and Software Update

ANSM issued a safety alert (Ref. R2604745) requiring Philips Respironics Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 ventilators to receive mandatory software updates and discontinue use of non-pneumatic nebulizers. The alert addresses incorrect tidal volume delivery when non-pneumatic nebulizers are used due to faulty leak estimation, and corrects alarm delay delays and flow sensor anomalies caused by aerosol accumulation. Healthcare providers and home health service providers (PSAD) must act immediately.

Lifecath PICC Easy Central Venous Catheter Lot Recall

ANSM issued safety alert R2608397 regarding a product recall by Vygon Germany GmbH for Lifecath PICC Easy central venous catheters. The recall affects specific lots distributed to French pharmacies and health establishments. Healthcare facilities must identify and return affected products immediately.

Sphere-9 Dual-Energy Mapping and Ablation Catheter Safety Recall

ANSM has recorded a field safety corrective action by Medtronic for the Sphere-9 dual-energy mapping and ablation catheter system (combining electroporation and radiofrequency) under reference R2608484. Healthcare establishments must review the Medtronic safety letter and take appropriate action regarding affected devices.

TruPulse Ablation Generator Safety with Thermocool Catheter

ANSM issued safety notification R2608394 regarding a field safety corrective action by Biosense Webster Inc. for the TruPulse cardiac ablation generator (software version 2.7.0) when used with the Thermocool SmartTouch SF dual-energy catheter. Healthcare facilities using this equipment must review the manufacturer's safety communication dated March 30, 2026.

SureForm 30 8mm Surgical Stapler Recall

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.