MedWatch Safety Alerts

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

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

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

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

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

Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula

The Shiley Adult Flexible Tracheostomy Tube is being recalled as it may come loose if the flange disconnects, potentially leading to a blocked airway

Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic

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

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

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

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

Intra-Operative Positioning System Guidewire Recall: Centerline Biomedical Removes Certain IOPS Guidewires due to Delamination

Sensorized Guidewire Issue from Centerline Biomedical

Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly

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

Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System and Cheetah Delivery Tool After FDA Warning Letter About Internal Processes and Distal Tip Characteristics

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