HEALTH-CANADA

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.

Monoject Syringe Recall - Incorrect Insulin Labeling

Health Canada has issued a recall for Monoject 1mL Luer Lock Syringes due to incorrect insulin labeling. The outer packaging indicates a tuberculin syringe, but the syringes inside are U-100 insulin syringes. Healthcare providers are advised to contact the manufacturer for more information.

SOLTIVE Laser System Recall

Health Canada has issued a Type II recall for the SOLTIVE Premium SuperPulsed Laser System due to a defect in the 24V power supply causing sudden power loss. Affected healthcare providers should contact the manufacturer for service coordination.

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.

Instinct Plus Endoscopic Clipping Device Recall

Health Canada has issued a Type II recall for the Instinct® Plus Endoscopic Clipping Device manufactured by Wilson-Cook Medical, Inc. due to 486 reported malfunctions where the clip fails to open. This recall is to withdraw products manufactured prior to corrective actions being implemented.

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.

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.

Health Canada Recalls Nitrous Oxide Chargers

Health Canada has issued a recall for nitrous oxide chargers sold for inhalation without market authorization. Consumers are warned not to inhale these products recreationally and to seek medical attention if side effects occur. The recall affects multiple brands sold by Total Merchandise Ltd.

Monoject Syringe Recall

Health Canada has issued a Type II recall for Monoject 1mL Luer Lock Syringes due to incorrect labeling. The affected products are mislabeled as Tuberculin syringes but contain U-100 Insulin syringes. Healthcare providers are advised to contact the manufacturer for more information.

Health Canada Implements ICH Pharmaceutical Guidelines

Health Canada is implementing new International Council for Harmonisation (ICH) guidelines for pharmaceuticals, including M13A and Q12/Q14. These implemented ICH guidelines will take precedence over existing Health Canada guidance documents where discrepancies exist, potentially leading to amendments or withdrawals of current guidance.