ANSM Drug & Device Safety Alerts

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.

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.

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.

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.

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 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.

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.

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.

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.