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
Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape
The FDA is raising awareness about cybersecurity vulnerabilities with Contec CMS8000 and Epsimed MN-120 patient monitors
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) - including certain formulations of
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial
Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact
mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
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
The Shiley Adult Flexible Tracheostomy Tube is being recalled as it may come loose if the flange disconnects, potentially leading to a blocked airway
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code That May Stop Compressions or Deliver Inadequate CPR
GE HealthCare is correcting Carestations that may not ventilate properly in VCV mode. The issue is clearly indicated by alarms; other modes remain effective
Medline Industries is correcting certain lots of their medical procedure kits that contain a recalled Medtronic aortic root cannula
The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in
Sensorized Guidewire Issue from Centerline Biomedical
Blood Products Administration Sets recalled due to incorrect assembly. Use may lead to administration of unfiltered blood or delays in therapy
The Hippo 072 Aspiration System is used to remove stroke-causing clots but there may be issues with the distal tip during clot removal