Industry News
The latest medical device regulatory news, clinical trials, and market insights
Urgent Drug Warning: Outdated Patient Leaflet for Olmesartan Medoxomil Tablets
Jubilant Pharmaceuticals NV has reported a packaging error involving certain batches of Olmesartan medoxomil 10mg film-coated tablets. According to the…
Critical Recall Update: BD Alaris™ Pump Infusion Sets Expand Warning to Higher Risks
Medical technology manufacturer BD has announced an expanded voluntary recall of certain BD Alaris™ Pump Module model 8100 infusion sets.…
July 2025 MHRA Safety Update: Essential Guidance for Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety guidance aimed at users of medicines and…
FDA Alert: Tandem Diabetes Care Updates t:slim X2 Insulin Pumps Due to Potential Speaker Wiring Fault
Tandem Diabetes Care has issued an urgent correction addressing potential risks associated with certain t:slim X2 insulin pumps. Healthcare professionals,…
Fucidin 250 mg Tablets Recall Announced Due to Impurity Concerns
On September 30, 2025, LEO Pharma issued a recall notice for one batch of Fucidin 250 mg Tablets following routine…
FDA Issues Advisory: Medline Kits Potentially Contain Defective Medtronic Heart Ventilation Cannulas
The U.S. Food and Drug Administration (FDA) has released a critical early alert regarding certain Medline Convenience Kits, which may…
Critical Updates: Field Safety Notices for Medical Devices (28 July – 1 August 2025)
Between 28 July and 1 August 2025, healthcare teams were informed of updates to multiple Field Safety Notices (FSNs) related…
FDA Alert: mo-Vis BVBA Issues Firmware Update Recall for R-net Wheelchair Joysticks
Mo-Vis BVBA has announced an urgent firmware correction for their R-net joystick devices used in powered wheelchairs. This update responds…
Medical Alert: Label and Packaging Error Identified for Topiramate Zydus 20mg/ml Oral Solution
Zydus Pharmaceuticals UK Ltd has released a critical notification regarding an error on the packaging and patient information leaflet (PIL)…
FDA Warns Against Using Unauthorized Infant Vital Sign Monitors
The FDA issued a critical safety communication on September 16, 2025, advising against the use of unauthorized infant devices designed…
Critical Updates: Field Safety Notices Issued From 4 to 8 August 2025
Clinical, quality, and regulatory teams should note the latest field safety notices issued between 4 and 8 August 2025. These…
FDA Warns Against Unauthorized Blood Pressure Devices: What You Need to Know
The U.S. Food and Drug Administration (FDA) has issued an important safety communication regarding blood pressure measurement devices. This announcement,…