- Heart Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllersby FDAA software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.
- by FDAThe air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, affecting the delivered oxygen concentration
- by FDAAbiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.
- by FDACertain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis
- by FDALearn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.
- by FDACertain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile
- by FDAThe FDA issued a LHCP to notify providers that Stereotactic Breast Biopsy Needles (product code KNW) are experiencing a supply disruption.
- by FDADraeger is correcting additional anesthesia workstations due to a manufacturing error that may cause the ventilator to fail before or during use.
- by FDAMedline is correcting affected convenience kits by removing recalled Bupivacaine Hydrochloride in Dextrose Injection components.
- by FDARead the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.
- by FDAFOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA – Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp. Date 02/2028 of Beekeeper’s Naturals Saline Nasal Spray, sold only through Amazon, to the consumer level. This lot, produced at a third-party manufacturer, tested above our acceptable
- by FDACertain AIC units require hardware updates to address potential safety concerns that could lead to a delay or loss of hemodynamic support.
- by FDAVolara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
- by FDAThe FDA has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using
- by FDAFRANKLIN LAKES, N.J. (June 06, 2026) – BD (Becton, Dickinson and Company) is voluntarily recalling lot 4032183 of ChloraPrep™ Clear 1 mL Single Sterile and lot 4073005 of FREPP™ Clear 1.5 mL applicators with paper lidding to the consumer level. These products are being recalled due to fungal contami
- by FDAThe ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation
- by FDAGE HealthCare is correcting Carestations that may not ventilate properly in VCV mode. The issue is clearly indicated by alarms; other modes remain effective.
- by FDACertain Omnipod Pods may have a tear in the tubing that allows insulin to leak outside the Pod instead of being delivered to the body.
- Haleon Issues Voluntary Nationwide Recall of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct.by FDAWARREN, N.J., June 4, 2026 — Haleon (NYSE: HLN) is voluntarily recalling four lots of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct. distributed on or about April 13, 2026 to the consumer level. The lots are being recalled due to potential contamination with a diluted propylene glycol-based
- by FDAListing of Medical Device 2024 Safety Communications