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50 changes Enforcement, last 7 days

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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.

Priority review Enforcement Healthcare
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Integra LifeSciences Convenience Kit Needle Recall

The FDA is alerting the public about a recall initiated by Integra LifeSciences for certain Convenience Kit Needles, specifically the Codman Microsensor Basic Kits and Cerelink ICP Sensor Basic Kits. Affected customers and distributors are instructed to immediately remove these devices from service or distribution.

Urgent Enforcement Medical Devices
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DEA Seizes Over Half a Million Vape Cartridges and Drugs in San Diego

The DEA announced a massive seizure in San Diego, confiscating over half a million vape cartridges and other illicit drugs. This action highlights the ongoing threat posed by illegal substances to public health and safety, with multiple law enforcement agencies collaborating in the operation.

Urgent Enforcement Public Health
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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.

Urgent Enforcement Medical Devices
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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.

Urgent Enforcement Medical Devices
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Pure Vitamins LLC Recalls Honey Products Due to Undeclared Sildenafil and Tadalafil

Pure Vitamins and Natural Supplements, LLC is voluntarily recalling honey products marketed as sexual enhancement due to undeclared sildenafil and tadalafil. These undeclared ingredients can interact with prescription medications and cause dangerous drops in blood pressure.

Urgent Enforcement Healthcare
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Instinct Plus Endoscopic Clipping Device Recalled Due to Malfunctions

Health Canada has issued a Type II recall for the Instinct® Plus Endoscopic Clipping Device manufactured by Wilson-Cook Medical, Inc. due to malfunctions where the clip may remain attached to the drive wire and cannot be opened. This recall affects products manufactured prior to corrective actions being implemented.

Urgent Enforcement Healthcare
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Arjo Tenor Mobile Lift Recall

Health Canada has issued a Type II recall for the Arjo Tenor Mobile Lift due to a defect in the brake component of the actuator. The defect can cause a loss of self-locking and uncontrolled descent, posing a safety risk. Affected units must be removed from use immediately.

Urgent Enforcement Medical Devices
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SOLTIVE Premium SuperPulsed Laser System Recall

Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System manufactured by Gyrus Acmi, Inc. The recall is due to a defect in the 24V power supply causing sudden power loss or failure to power on. Affected customers will be contacted by Olympus representatives to schedule service.

Urgent Enforcement Medical Devices
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Arjo Tenor Mobile Lift Recall

Health Canada has issued a Type II recall for the Arjo Tenor Mobile Lift due to a brake defect that can cause uncontrolled descent. All affected units must be removed from service immediately until repaired by authorized personnel.

Urgent Enforcement Healthcare

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