Regulatory Affairs

FDA Issues Critical Recall of Zenith Alpha 2 Thoracic Endovascular Graft by Cook Medical

Healthcare providers and clinical teams should be aware that the FDA has classified a recall of COOK MEDICAL's Zenith Alpha…

Critical Recall of FDA-Regulated Products by Gold Star Distribution Due to Severe Contamination Risks

Gold Star Distribution, Inc., has issued an urgent recall of various FDA-regulated products across three states. This notice pertains to…

Critical Software Correction Announced for Dexcom G6 and G6 Pro Devices

Dexcom Inc. recently issued an urgent correction for its Dexcom G6 Continuous Glucose Monitoring (CGM) System’s Android US CGM App,…

Critical Update: Revised Operational Instructions for GE HealthCare Carestation Anesthesia Systems

Healthcare professionals and facility management teams utilizing GE HealthCare’s Carestation 600 and 700 Series Anesthesia Systems should be aware of…

FDA Identifies Critical Update Needs for Abiomed’s Automated Impella Controllers

The Food and Drug Administration (FDA) has announced a critical update for the use of Automated Impella Controllers (AIC) by…

FDA Highlights Serious Recall of ICU Medical IV Gravity Burette Sets Due to Safety Risks

The FDA has announced a critical recall concerning ICU Medical Inc.’s IV Gravity Burette Sets, which are used for intravascular…

Alcon Recalls Custom Pak Ophthalmic Procedure Packs Over Sterility Concerns

Alcon has initiated a voluntary recall involving certain Custom Pak Ophthalmic Procedure Packs due to concerns over potential sterility compromises.…

FDA Alert: Updated Instructions Issued for Calyxo CVAC Aspiration Systems

Calyxo Medical has issued an urgent update regarding the safe use of its CVAC Aspiration Systems. Health care providers and…

Critical FDA Alert: Fresenius Kabi Recalls Ivenix Infusion Pumps Due to Misassembly Risk

On January 10, 2026, the FDA issued an update regarding Fresenius Kabi’s recall of specific Ivenix Large Volume Pump (LVP)…

FDA Announces Critical Recall of Bravo CF Capsule Delivery Devices Due to Serious Safety Risks

Medtronic and its subsidiary Given Imaging Inc. have initiated a major recall of certain Bravo CF capsule delivery devices used…

Critical Recall of Novasight Hybrid Catheters Due to Potential Safety Risks

The FDA has announced a critical recall of the Novasight Hybrid catheters, manufactured by Conavi Medical Inc., due to safety…

Critical Recall: Baxter Sigma Spectrum Infusion Pumps Removed Due to Software Risks

The FDA has issued a notice regarding the urgent recall of specific Baxter Sigma Spectrum Infusion Pumps due to software…