This recall involves updating instructions for using 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 following the updated instructions.   Affected Product Product…

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 Image A: Adaptors provided in the accessory bag of the AirLife Infant Heated Wire Circuit….

AUDIENCE: Patient, Health Care Professional, Pharmacy, Pediatrics ISSUE: 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 younger than 6 years taking these…

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 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 Abiomed has issued a letter…

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 issue. The FDA will keep the public informed and update this web page as significant new information becomes available.  Affected Product  Spectrum V6 infusion pump startup screen Spectrum V8 infusion pump…

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:…

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,…

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…

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…

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…