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Certain AIC units require hardware updates to address potential safety concerns that could lead to a delay or loss of hemodynamic support.
Early Alert: Positive Pressure Breathing Device Issue from Baxter
Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury
The 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
Early Alert: Breathing Circuit Set Issue from Hamilton Medical
The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation
BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination
FRANKLIN 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
Early Alert: Infant Resuscitation System Issue from GE HealthCare
The air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, affecting the delivered oxygen concentration
Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations due to Risk of Ineffective Ventilation When Used in Volume Control Ventilation (VCV) Mode
GE HealthCare is correcting Carestations that may not ventilate properly in VCV mode. The issue is clearly indicated by alarms; other modes remain effective.
Haleon Issues Voluntary Nationwide Recall of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct.
WARREN, 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
Anesthesia Kit Correction: Becton Dickinson Issues Correction for BD Spinal Trays Containing Bupivacaine Ampules
BD is correcting affected Spinal Trays by removing Bupivacaine ampule components
UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system or who have one; recommendations for health care providers.
2024 Safety Communications
Listing of Medical Device 2024 Safety Communications
Early Alert: Catheter Introducer Kit Issue from Abiomed
Prolonged use of the Abiomed 14Fr Low Profile Introducer may lead to thrombus formation
Dexcom Uncovers Theft of Scrapped Product, Notifies Potentially Impacted Users
SAN DIEGO – MAY 26, 2026 – DexCom, Inc. (Nasdaq: DXCM), the global leader in glucose biosensing, announced today through ongoing quality and accounting reviews it recently identified certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the
Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds
If the hand controls to adjust the bed are not locked, children could adjust the bed and become entrapped.
Early Alert: IV Tubing Set Issue from ICU Medical
Black specks and particulate matter have been reported in the drip chamber of certain ICU Medical IV tubing sets
Early Alert: Heart Pump Issue from Abiomed
Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
Early Alert: Heart Pump Issue from Abiomed
Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets
ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation, Inc. (NASDAQ: PODD) (“Insulet” or the “Company”) today announced a voluntary Medical Device Correction for specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue, identif
Manifold Recall: Medline Removes Namic Star Off Handle Manifolds
Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
Dialysis Catheter Kit Recall: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers
Arrow International is removing dialysis catheter kits containing recalled Merit Medical Splittable Sheath Introducers
