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Class I Recall Notice: Intra-Operative Positioning System Guidewire Issue from Centerline Biomedical fda.gov/medical-device…

Infusion Pump Recall: Zyno Medical Removes Certain Z-800 Series Infusion Pumps due to Software Issue fda.gov/medical-device…

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 fda.gov/medical-device…

Convenience Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL Endotracheal Tubes due to Smaller than Expected Tube Diameter That May Cause Underventilation fda.gov/medical-device…

Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly fda.gov/medical-device…

Little Remedies Honey Cough Syrup by Medtech Products: Recall - Due to Microbial Contamination fda.gov/safety/recalls…

Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch fda.gov/safety/medical…

Outbreak Investigation of Listeria monocytogenes: Chicken Fettuccine Alfredo Meals (June 2025) - Do Not Eat or Serve Recalled Chicken Fettuccine Alfredo Meals Made by Certain FreshRealm, Inc. Facilities. FDA’s Investigation is Ongoing fda.gov/food/outbreaks…

Anesthesia Delivery Systems Recall: GE HealthCare Issues Correction for Certain Carestations Due to Risk of Ineffective Ventilation When Used in Volume Control Ventilation Mode fda.gov/medical-device…

Medical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Procedure Kits Containing Medtronic Aortic Root Cannulas Due to Potential Excess Material in Male Luers fda.gov/medical-device…

Resuscitation System Recall: ZOLL Circulation, Inc. Recalls AutoPulse NXT Resuscitation System Due to Failure Code That May Stop Compressions or Deliver Inadequate CPR fda.gov/medical-device…

Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic fda.gov/medical-device…

Import Alerts for Certain Olympus Medical Devices Manufactured in Japan fda.gov/medical-device…

Angiographic Catheters Recall: Cook Inc. Removes Beacon Tip Angiographic Catheters Due to Tip Separation fda.gov/medical-device…

mRNA COVID-19 Vaccines: FDA Safety Communication - FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination fda.gov/safety/medical…

One Lot of Cefazolin for Injection by Sandoz: Recall - Due to Product Mispackaging fda.gov/safety/recalls…

Early Alert: Infusion Pump Software Issue from Baxter fda.gov/medical-device…

Early Alert: Blood Pump Controller Issue from Abiomed fda.gov/medical-device…

Extended-Release Stimulants for ADHD: FDA Drug Safety Communication - FDA Requires Expanded Labeling about Weight Loss Risk in Patients Younger than 6 Years. Action Will Harmonize Labeling Across Extended-Release Stimulant Drug Class fda.gov/safety/medical…

UPDATE: Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication fda.gov/medical-device…