This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.

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

Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.

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 amphetamine and methylphenidate - to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo

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.

mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination

Affected device lots may experience tip separation; field complaints reported that the tip separation can occur both prior to and during patient contact.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

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.

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

Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to a Failure Code That May Stop Compressions or Deliver Inadequate CPR

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

Scientific studies of artificial intelligence (AI) solutions in healthcare have been the subject of intense criticism—both in research publications and in the media.1–3 Early validations of predictive algorithms are criticised for not having meaningful clinical impact, and AI tools that make mistakes or fail to show immediate improvement in health outcomes are heralded as the first snowflakes in the next AI winter (a period of decreased interest in AI research and development). Scientific evidence is the language of trust in healthcare, and peer-reviewed studies evaluating AI solutions are key to fostering adoption. There are over two dozen reporting guidelines for AI in medicine,4 and many other consensus statements and standards that offer recommendations for the publication of research about medical AI.5 Despite such guidance, the average frontline clinician still struggles in interpreting the results of an AI study to...