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This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramView the full article

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

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 yoView the full article

Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.View the full article

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

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

This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramView the full article

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.View the full article

GE HealthCare is correcting Carestations that may not ventilate properly in VCV mode. The issue is clearly indicated by alarms; other modes remain effective.View the full article

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

Medline Industries is correcting certain lots of their medical procedure kits that contain a recalled Medtronic aortic root cannulaView the full article

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 oView the full article

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Medline Neonatal and Pediatric convenience kits that include Smiths Medical ORAL/NASAL Endotracheal Tubes are used for intubation.View the full article

Blood Products Administration Sets recalled due to incorrect assembly. Use may lead to administration of unfiltered blood or delays in therapy.View the full article

The Hippo 072 Aspiration System is used to remove stroke-causing clots but there may be issues with the distal tip during clot removal.View the full article

Infusion pumps released with incorrect software can experience unexpected performance problems, including issues with essential functions and risk measures.View the full article

Sensorized Guidewire Issue from Centerline Biomedical View the full article

Nipro recalls bicarbonate dialysate concentrate due to contamination. Learn about potential serious injuries, fatality risks and essential steps for healthcare providers and patients for this Class I recall. View the full article

In May 2025, Medtronic issued a voluntary recall notification to global customers related to specific Newport™ HT70 and HT70 Plus ventilators and certain related Newport™ service parts. The FDA recently designated this voluntary action by Medtronic as a Class I recall. With this recall, Medtronic iView the full article

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Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level. View the full article

Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for UnderinfusionView the full article

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Infusion Pump Thermal Damage Issue from Smiths MedicalView the full article