The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Trilogy Evo ventilator Repair kits for Trilogy Evo muffler assembly* Model Numbers: Manufacturing Dates: April 15, 2021 to May 24, 2021 Distribution Dates: April 15,…
Tips for Women to Prevent Heart Disease
Image Español More women die from heart disease than from any other cause: about one in five American women, according to the Centers for Disease Control and Prevention. You can take action now to reduce your risk. Resources from the U.S. Food and Drug Administration (FDA) can help women of all ages learn how to…
Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch
Summary Company Announcement Date: January 18, 2022 FDA Publish Date: January 19, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Missing Label Company Name: Mylan Pharmaceutical Inc. Brand Name: Brand Name(s) Product Description: Product Description Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens Company Announcement PITTSBURGH – Jan. 18, 2022 – Mylan…
Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product HawkOne Directional Atherectomy System Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 95,110 Distribution Date: January 22, 2018 to October…
UPDATE: Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel
January 19, 2022 The U.S. Food and Drug Administration (FDA) is aware the United States is experiencing significant interruptions in the supply of several blood specimen collection (blood draw) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges. The FDA is expanding the medical device shortage…
Problems with E-Cigarettes, Vape Products, Hookah, Cigarettes or Other Tobacco Products? Tell FDA
Español Have you used an e-cigarette, cigar, cigarette, hookah, smokeless tobacco or other tobacco product that you believe is not working properly or that is causing an unexpected health problem? Does the product have a strange taste or smell; has your vape battery exploded; or is there some other problem or concern? The U.S. Food…
Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Vaporizer Sevoflurane, Maquet Filling for Flow Family Anesthesia Systems Model Number: Model 6886601 Manufacturing Dates: December 15, 2020 to July 21, 2021 Distribution Dates: February…
FDA D.I.S.C.O. Burst Edition: FDA approval of Orencia (abatacept) for prophylaxis of acute graft versus host disease
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On December 15, 2021, the FDA approved abatacept (brand name…
Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use
Summary Company Announcement Date: January 12, 2022 FDA Publish Date: January 12, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Hub cap and seal on the proximal end of the device handle may detach during use Company Name: Oscor Inc. Brand Name: Brand Name(s) Product Description: Product Description Destino Twist 14F model…
Buprenorphine: Drug Safety Communication – FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
[Posted 01/12/2022] AUDIENCE: Dentistry, Anesthesiology, Patient, Health Professional, Pharmacy ISSUE: The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of…