The FDA has announced a critical recall concerning ICU Medical Inc.’s IV Gravity Burette Sets, which…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
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.…
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…
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…
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…
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…
Urgent FDA Recall: Serious Safety Risks Linked to Bard PowerPICC Catheters
The FDA has issued an urgent recall for specific Bard PowerPICC Intravascular Catheters. Healthcare providers and…
Critical FDA Alert: AVID Medical Updates on Organ Recovery Kits to Address Safety Risks
The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning Organ Recovery Packs…
Nationwide Recall of Silintan Capsules Due to Undeclared Meloxicam: Safety Risks Highlighted
An urgent recall has been issued for Silintan capsules by Anthony Trinh, 123Herbals LLC, following FDA…