ANSM Drug & Device Safety Alerts

Electric Scalpel HF Bipolar Cable Safety Information

The ANSM has issued a safety alert regarding an action taken by Olympus Winter & IBE GmbH concerning their electric scalpel HF bipolar cable. Healthcare facilities have been informed of this safety action, registered under number R2607994.

Safety Recall: Omnipaque and Visipaque Injectable Solutions

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety recall for specific lots of Omnipaque and Visipaque injectable solutions manufactured by GE Healthcare SAS. The recall is due to the potential presence of particles adhering to the inner wall of the vials, posing a risk to patients if injected.

ANSM Safety Alert: Atellica CH Urine Albumin Reagent

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Atellica CH Urine Albumin reagent from Siemens Healthcare Diagnostics Inc. The alert, registered under number R2602998, informs medical biology laboratories of a safety action implemented by the manufacturer.

ANSM Security Alert for Orbis Medication Prescription Aid Software

The ANSM has issued a security alert (R2608925) regarding the Orbis Medication prescription aid software (version 3.x) from DH Healthcare GMBH. Affected healthcare providers have been notified directly by the company.

Product Recall: Klassiker Crutches and Rubber Tips

The ANSM has been informed of a product recall for Klassiker crutches and rubber tips, initiated by Ossenberg GmbH. This safety action, registered under number R2603198, affects pharmacies, community care facilities, large and medium-sized stores, and home healthcare providers. Affected users have been notified directly by the manufacturer.

Resoundant Acoustic Transducer for MRI - Safety Action

The French National Agency for Medicines and Health Products Safety (ANSM) has registered a safety action concerning the Resoundant acoustic transducer for MRI, identified under number R2606244. Healthcare facilities and medical imaging centers using this device have been notified.

Rivaroxaban Viatris 20 mg tablet safety information

The French National Agency for the Safety of Medicines and Health Products (ANSM) has issued safety information regarding Rivaroxaban Viatris 20 mg tablets. This alert highlights specific safety considerations and potential risks associated with the use of this medication.

ANSM Safety Information for Pre-analytical Tube

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety recall (R2607993) for the Vacuette CTAD 3.5ml pre-analytical tube manufactured by Greiner Bio-One. Affected medical laboratories have been notified directly by the manufacturer.

ANSM Drug & Device Safety Alert: Recall of Anti-Ig M-PER Reagent

The French ANSM has announced a recall of a specific lot of the Anti-Ig M-PER reagent used in Hydragel kits by Sebia. This safety action, registered under number R2607839, is intended for medical biology analysis laboratories.

ANSM Safety Alert: Radius VSM ECG Electrodes and Blood Pressure Cuffs

The French ANSM has issued a safety alert regarding a lot recall of Radius VSM ECG electrodes and blood pressure cuffs by Masimo Corporation. This action is registered under recall number R2607611 and is directed at pharmacies and healthcare facilities.

ANSM Safety Information: Urology/Gynecology Suction Device

The French ANSM has been informed of a lot recall initiated by Clinical Innovations, LLC for their KIWI Omni Vacuum Delivery System suction device. This safety action is registered under number R2607844 and is directed at pharmacies and healthcare facilities.

ANSM Safety Alert: Kwik-Stik and Lyfo Disk Campylobacter jejuni Controls

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding bacteriology controls for Kwik-Stik and Lyfo Disk Campylobacter jejuni products from Microbiologics. This notice informs laboratories of a security action implemented by the manufacturer.

ANSM Safety Alert: Manual Ventilator

The French ANSM has updated a safety alert regarding manual ventilators (Bavu) manufactured by Intersurgical. This update expands the scope of devices affected by a previous safety action initiated in May 2025, with users receiving updated correspondence.

ANSM Safety Recall: Quadripod Cane 548 bis HMS-Vilgo

The French National Agency for Medicines and Health Products Safety (ANSM) has announced a safety recall (R2608257) for the Quadripod cane model 548 bis HMS-Vilgo, initiated by the manufacturer HMS-Vilgo. The recall is directed at pharmacies, healthcare facilities, and home health providers.

ANSM Safety Information: Thoraflex Hybrid Thoracic Aorta Prosthesis

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Thoraflex Hybrid thoracic aorta prosthesis manufactured by Vascutek Ltd. Healthcare providers have been notified of a safety action implemented by the manufacturer.

ANSM Safety Information: Vitros MicroSlide Mg Reagent

The French ANSM has issued a safety alert regarding the Vitros MicroSlide Mg reagent from QuidelOrtho. Affected users have been notified directly by the company, and the action is registered under ANSM number R2607971. This notice provides information and a link to the company's safety communication.

ANSM Safety Alert: Space Plus Perfusor Syringe Pump by B Braun

The French National Agency for the Safety of Medicines and Health Products (ANSM) has issued a safety alert regarding the Space Plus Perfusor syringe pump manufactured by B Braun Melsungen AG. This alert informs healthcare facilities and pharmacies about a safety action implemented by the manufacturer.

Philips Radiology Device Safety Alert

The French ANSM has been informed of a safety action initiated by Philips Medical Systems Nederland BV concerning radiology devices. Affected users have received a direct communication from the company regarding this action, registered under ANSM reference R2606927.

ANSM Safety Alert: Eonis SCID-SMA Kit for Genetic Testing

The French ANSM has issued a safety alert regarding the Eonis SCID-SMA kit for genetic testing, manufactured by Wallac/Revvity. Affected users have been notified directly by the company, and the alert is registered under ANSM reference R2607970.

Product Recall: Artis PL E and Artis Symbiose Intraocular Lenses

The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced a product recall for Artis PL E and Artis Symbiose intraocular lenses manufactured by Cristalens Industrie. This safety action, registered under number R2606056, requires healthcare facilities to take immediate action regarding the affected lots.

Curosurf Safety Information and Lot Recall

The French drug agency ANSM, in agreement with Laboratoire Chiesi SAS, has initiated a recall of one lot (Lot 1204229, Exp 04/2026) of Curosurf 120 mg/1.5 ml suspension for endotracheobronchial instillation. This precautionary measure follows a deviation observed during environmental monitoring at the production site.

ANSM Security Alert for EdgeSuite Software and EdgeLab Module

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a security alert regarding the EdgeSuite software and EdgeLab module from In Log. Affected medical analysis laboratories have been notified directly by the company.

ANSM Safety Alert: B. Braun Infusion Sets and Mentor Tissue Expanders

The ANSM has issued a safety alert regarding specific lots of B. Braun infusion sets and Mentor tissue expanders. A lot recall has been implemented by the manufacturer, B. Braun Medical Inc., and Mentor. Affected users have been notified.

ANSM Safety Alert for Soltive SuperPulsed Laser Systems

The French ANSM has issued a safety alert (R2607992) regarding Soltive SuperPulsed laser systems, following a security action initiated by Olympus. Affected users have been notified directly by the manufacturer.

Philips Respironics BiPAP A40 Pro Ventilator - Discontinuation and Safety Alert

Philips Respironics is discontinuing the BiPAP A40 Pro ventilator globally due to an internal oxygen sensor defect causing false alarms. The company offers patients options for continued care, including device replacement or partial reimbursement. Healthcare providers must inform affected patients of these options.

Curosurf 240 mg/3 ml Suspension Recall by Chiesi SAS

The French ANSM has announced a recall of a specific lot (Lot 1211845, Exp 07/2026) of Curosurf 240 mg/3 ml suspension for endotracheobronchial instillation. This action was initiated by the manufacturer, Chiesi SAS, as a precautionary measure due to a resolved deviation observed during environmental monitoring.

Philips Spectral CT Scanner Software Safety Alert

The French ANSM has issued a safety alert (R2607608) regarding Philips Spectral CT scanner systems with software version 5.1.X. Healthcare facilities using these devices have been notified of a security action initiated by Philips Medical Systems BV.

Leksell Vantage stereotactic system safety information

The French ANSM has issued a safety notice regarding the Leksell Vantage stereotactic system by Elekta Ltd. This action, registered under number R2607991, is based on a safety action implemented by the manufacturer. Affected healthcare facilities have been notified.

ANSM Drug & Device Safety Alert: Endoscopic Clip Device

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.

ANSM Safety Information for Hemostasis Reagent STA NeoPTimal 5

The French ANSM has issued a safety information notice regarding the Hemostasis Reagent STA NeoPTimal 5, manufactured by Diagnostica Stago. Affected users have been notified directly by the company, and the action is registered under ANSM number R2607353.

ANSM Safety Recall: Autoimmunity IDS SS-A/Ro Reagent

The French ANSM has issued a safety recall (R2532493) for a specific lot of the Autoimmunity IDS SS-A/Ro reagent manufactured by Immunodiagnostic Systems (IDS). Laboratories using this reagent have been notified directly by the manufacturer.

Neonatal incubator safety alert: Lifetherm 2000

The ANSM has issued a safety alert regarding the Lifetherm 2000 neonatal incubator manufactured by Löwenstein Medical GmbH & Co. KG. The alert, registered under number R2607231, concerns a specific healthcare facility and includes a letter from the manufacturer detailing the safety action.

Impella AIC consoles with software <10.1 and Impella 5.5 first-gen safety alert

The ANSM has been informed of a safety action by Abiomed concerning Impella AIC consoles with software versions prior to 10.1, when used with first-generation Impella 5.5 ventricular assist devices. Healthcare providers using these devices have received specific instructions from Abiomed.

Stryker Osteosynthesis Screws Recalled Due to Safety Concerns

The French ANSM has announced a recall of Stryker osteosynthesis screws (7.0 mm Darco headless screws, 16x60 mm) due to safety concerns. This action, registered under recall number R2606623, affects pharmacies and users who have received direct communication from Stryker Instruments.

Product Recall: Mako Surgical Corp. MICS3 Fixation Device

The ANSM has announced a product recall for the Mako Surgical Corp. MICS3 fixation device, registered under recall number R2606434. The recall targets pharmacies and healthcare facilities, with two identified users having received direct communication from the manufacturer.

Polysilane UPSA gel oral recall notice

The ANSM has issued a recall notice for specific lots of Polysilane UPSA oral gel due to the potential presence of food-grade joint particles. The recall is a precautionary measure affecting the distribution chain, and the product will be unavailable until the issue is resolved.

ArjoHuntleigh Tenor Mobile Hoist Safety Alert

The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced a product recall for the ArjoHuntleigh Tenor mobile hoist. This action, registered under number R2606757, is being implemented by the manufacturer ArjoHuntleigh AB.

ANSM Safety Information: Mobile Hoist and Bath Elevator

The French National Agency for Medicines and Health Products Safety (ANSM) has issued safety information regarding a mobile hoist and bath elevator from Mangar International. This notice, registered under number R2607055, alerts home healthcare providers and retailers to a safety action implemented by the manufacturer.

Safety alert for DermaGenius 3.0 reagent

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the DermaGenius 3.0 Complete Multiplex real-time PCR reagent. This alert, registered under number R2607183, informs medical biology analysis laboratories of a security action implemented by PathoNostics.

Spinal Plug Safety Alert for Pharmacies

The French ANSM has been informed of a lot recall action for spinal plugs (Airplug T10-T12) by Groupe Lépine, registered under action number R2607057. Pharmacies are directed to consult the provided letter from the manufacturer for details.

ANSM Safety Alert for Manosplint Cushionfoam Medical Device

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Manosplint Cushionfoam medical device, identified by safety action number R2606620. This alert concerns a safety action initiated by the manufacturer, Kinetec SAS.