This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name: AutoPulse NXT Platform Model: Model 200 Catalog Number: 8700-001070-1 Software Version:…
mRNA COVID-19 Vaccines: FDA Safety Communication – FDA Approves Required Updated Warning in Labeling Regarding Myocarditis and Pericarditis Following Vaccination
AUDIENCE: Pediatrics, Pharmacy, Family Practice, Internal Medicine, Cardiology ISSUE: FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. Specifically,…
Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
Summary Company Announcement Date: June 27, 2025 FDA Publish Date: June 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Penicillin G Potassium Injection Vial Company Name: Sandoz Inc. Brand Name: Brand Name(s) Product Description: Product Description Cefazolin for Injection, USP, 1 gm vial Company Announcement Sandoz, Inc. (“Sandoz”) is…
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
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Medline Kits Containing Medtronic…
Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers
June 24, 2025 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. Despite extensive and ongoing efforts to address compliance issues, FDA continues to have concerns related to outstanding Quality System regulation violations…
Angiographic Catheter Recall: Cook Removes Beacon Tip Angiographic Catheters due to Tip Separation
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product What to Do On May 15, 2025, Cook sent all affected customers a letter recommending…
Early Alert: Esophageal pH Monitoring Capsule Issue from Medtronic
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected Product The FDA is aware that Medtronic and their subsidiary…
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
This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product • Product Names: Carestation 620/650/650c and 750/750c Anesthesia…
Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication – FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch
AUDIENCE: Patient, Health Care Professional, Neurology ISSUE: 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 older, who may…
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
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Products Product Name Product Code UDI NEONATAL INTUBATION TRAY ACC010371C 10193489268188 NEWBORN RESUSCITATION KIT ACC010381A 10193489800944 …