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The FDA is alerting health care providers to the recall of certain VasoView HemoPro devices due to risk of silicone detachment during use, and supply concerns.
Early Alert: Infusion Set Performance Issue from BD
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching...
HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry
Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa
Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility
Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.
Infant Breathing System Recall: AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation
AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.
Broselow Pediatric Emergency Rainbow Tape Recall: AirLife Removes Certain Broselow Pediatric Emergency Rainbow Tapes due to Misprinted Information
Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape.
Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication
The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors.
Early Alert: Infusion Pump Software Issue from Baxter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Extended-Release Stimulants for ADHD: FDA Drug Safety Communication - FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 Years
The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) - including certain formulations of amphetamine and methylphenidate - to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo
Early Alert: Blood Pump Controller Issue from Abiomed
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.
mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation
Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact.
Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Import Alerts for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries.
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.
Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannula due to Potential Excess Material in Male Luers
Medline Industries is correcting certain lots of their medical procedure kits that contain a recalled Medtronic aortic root cannula
Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code That May Stop Compressions or Deliver Inadequate CPR
Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code That May Stop Compressions or Deliver Inadequate CPR
Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch
The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and o
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