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

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

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

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

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

Sensorized Guidewire Issue from Centerline Biomedical

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.

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 i

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.

Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion

False Alarm Issue with Infusion Pump from Smiths Medical

Infusion Pump Thermal Damage Issue from Smiths Medical

Infusion Pump Intermittent Connection Issue from Smiths Medical

Breathing circuits may develop cracks during use, potentially causing ventilation leaks that can result in hypoxia or hypercarbia.

Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion