Safety Signal

Sellers and distributors are mandated to cease the sale and distribution of the affected products immediately and comply with penalties for non-compliance, which may include fines up to RM50,000 or imprisonment.

Sellers must stop the sale and distribution of the canceled products immediately and monitor for compliance with NPRA regulations to avoid legal penalties.

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

Immediately stop using the recalled stools, store away from children, and contact Wan Yi (866-677-3889 / customerservice-ca@cosyland.com) to request free repair parts (protective nets, stabilizing feet, instructions).

Identify and quarantine affected ARTIS Icono systems in inventory; contact manufacturer for update guidance.

Immediately stop use; visit Wyze Labs website for refund process. Report incidents to Health Canada.

Stop using affected batches; return to place of purchase for full refund.

Return recalled products to place of purchase for refund or contact Customer Care for return arrangements.

Identify and quarantine products from lots 1725204004 and 1725069002; contact patients who received sensors from these lots; report adverse events if any.

Identify affected lots and implement recall procedures as per Health Canada guidelines.

Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.

1) Verify your internal signal assessment narrative for GLP-1 RAs reflects FDA’s statement that the preliminary evaluation does not suggest a causal link; 2) Check whether any company-facing statements, FAQs, or labeling change proposals referencing suicidality need to be updated for consistency with FDA’s current public position; 3) Log the FDA update in regulatory intelligence tracking and maintain monitoring for further FDA conclusions or requests (including the linked 13 Jan 2026 communication).

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Laboratories must implement the safety measures as indicated by the action registration number R2625739, effective from the notice date of September 7, 2026.

Clinics and healthcare facilities are required to verify their inventory immediately and isolate any affected units to prevent accidental use.

Healthcare facilities must isolate the affected instruments and notify Intuitive Surgical for returns while preparing for potential delays in surgical procedures due to instrument replacements.

Healthcare providers using da Vinci X and Xi instruments must report any incidents associated with cable degradation and follow updated guidelines for the safe use of these instruments.

Health professionals must ensure adherence to the manufacturer’s instructions when using the affected devices, including appropriate trocar size selection and avoiding excessive force.

Regulatory Intelligence teams must initiate checks to monitor compliance and management of this recall, ensuring affected lots are removed from distribution.

Monitor the supply chain developments and prepare to adjust inventory management practices as the end of the shortage approaches.

Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.

Signal management teams need to prepare for potential updates in labeling, usage guidelines, and monitoring requirements for injectable iron-containing medicines.

MAHs of products containing phenobarbital must monitor new cases of AHS and submit yearly updates to IRIS. The annual statement submission deadline is set for the end of November each year.

UKHSA has implemented control measures to destroy larvae and is monitoring the area closely for further mosquito activity.

Healthcare professionals and consumers are directed to report any adverse events related to the use of ZUBB Dietary Supplement to the FDA's MedWatch Program.

Healthcare professionals must act on the issued FSNs as outlined by MHRA, ensuring compliance to address any safety concerns associated with the listed medical devices.

Users of affected products must conduct thorough visual inspections of the VentStar circuits prior to use and will receive free replacements for any affected circuits.

Philips is implementing a corrective safety action, and users must respond within 30 days to the included response form to address this safety concern. The modified cable expected to rectify the issue will be available by January 2027.

Healthcare establishments must quarantine the affected Eyefill C lots, refrain from using them, and monitor patients who received the device.

Users must ensure systems remain connected to power, conduct proper startup procedures, perform preoperative checks, and have emergency ventilation plans in place. Acknowledgment of receipt of the safety notice is required within 30 days.

Users are required to monitor inventory for affected lots and comply with instructions for potential disposal according to updated guidance from Microgenics Corporation.

Users must perform a software update to disable remote control and speed regulation for e-motion systems before January 1, 2021, using the Mobility application (version V01.004). For newer models, users need to safely store QR code labels after pairing.

Healthcare facilities are advised to adhere to standard acquisition protocols or modify parameters as recommended, with a requirement to respond to Philips within 30 days of notification.

Healthcare facilities using the affected Newport HT70 and HT70 Plus ventilators need to cease their use and evaluate the risk for their patients, following established protocols for device monitoring and replacement.

All customers handling Infinion CX Leads must stop using these devices, segregate them, and return them to Boston Scientific as per the recall protocol communicated on June 17, 2026.

Users must carefully inspect the VentStar Resus Neo hoses for damages as per the product's Instructions for Use (IFU) and discard any hoses showing signs of cracks or detachments before use.

Immediate quarantine and destruction of all affected lots are mandated. Affected inventory must be checked, and customers must be notified if products have been resold or transferred.

Enhanced monitoring for products with hidden drug ingredients is required, leading to increased need for rapid reporting and investigation of adverse events associated with similar products.

Update local protocols to ensure parenteral nutrition is administered with filters in compliance with the new requirements.

Healthcare professionals should not initiate treatment with Avacopan Vifor for new patients and must review existing patients' treatment plans to ensure safe transitions to alternative therapies.

Increased vigilance and reporting obligations on illegal peptide products, with an emphasis on monitoring and managing safety signals pertaining to these substances.

Healthcare providers and distributors must immediately identify and quarantine affected products before destroying them after completing the recall actions. Compliance with FDA recall procedures is mandatory.

AZRL LTD must proceed with the recall of FastPen 40mg from all locations and suspend marketing activities until compliance is verified.

Healthcare facilities must complete preoperative checks, manage emergency O2 flow during usage, and return the response form to GE Healthcare within a maximum of 30 days.

All users of the affected analyzers are required to reply to the notification letter within 10 days and implement increased monitoring of device performance to prevent liquid leaks.

Laboratories must immediately quarantine and return the affected product, and communicate with patients to manage their follow-up testing appropriately.

Monitor and evaluate the drug misuse trends and health impacts associated with ketamine, focusing on the increase in seizures as part of public health and law enforcement strategies.

Customers are required to quarantine affected kits, complete response forms, and destroy the kits. Notification must also be sent to distributors who should inform their customers of these updated actions.

Health care professionals must complete and return the enclosed Reply Verification Tracking Form (RVTF) indicating the quantities of affected units to return, and monitor patients following the standard of care while discontinuing the use of these catheters.

Implement enhanced surveillance and tracking of Salmonella cases linked to imported eggs, potentially increasing ICSR submissions related to these infections.

Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.

Customers must immediately identify and quarantine all unused affected devices (Bravo CF capsule delivery devices, product numbers FGS-0635 and FGS-0636) and return them to Medtronic for replacement.

Health professionals and stakeholders should review the safety signals linked to CAROTONE products in their signal management processes.

Healthcare providers must implement a follow-up process for patients with identified cobalt-chrome modular neck components, monitoring for new or unexpected symptoms including pain, stiffness, or instability.

Affected healthcare facilities should remove all Automated Impella Controllers from use and stock, ensure annual preventive maintenance is followed, and report any adverse reactions to Abiomed or MedWatch.

Submit bluetongue samples to APHA with forms attached securely on the outside of the parcel to facilitate rapid booking into their digital sample handling system.

Monitor and reassess affected pain and arthritis products, ensuring compliance with safety reporting protocols for products listed with known hidden ingredients.

Consumers should consult healthcare professionals if using this product and report any adverse effects to FDA’s MedWatch Safety Information.

Organizations must enhance signal management processes to track and report adverse events related to Melanotan II products, ensuring compliance with safety regulations.

Implement an immediate review of affected vaccine lots and ensure all relevant stakeholders are informed of the compliance issues for Signal Management processes.

Organizations must increase scrutiny and evaluation of vaccine safety profiles for lots identified in the notification of non-compliance.