Woodside Acquisitions Inc. recalls COVID-19 Rapid Test Kits because they are not authorized, cleared, or approved by the FDA.
Avanos Medical CORTRAK*2 Enteral Access System is being recalled because misplaced enteral tubes may cause patient harm.
The FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests. The test?s performance has not been adequately established.
SML Distribution Recalls Unauthorized COVID-19 Direct Antigen Rapid Tests because they are not authorized, cleared, or approved by the FDA.
Mesa BioTech?s Accula SARS-CoV-2 Tests are being recalled because facility contamination may cause them to give false positive results.
The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines
COVID-19 Ag Rapid Tests are being recalled because they may have been distributed to unauthorized, non-CLIA-certified users.
The FDA is issuing this letter to ensure you are aware of this defect and the recommended actions to take to manage the care of patients currently implanted with a Medtronic HVAD system.
The FDA has received reports of airway obstruction and ventilation failure for certain EMG endotracheal tubes.
The capsule at the end of the delivery catheter used to place Harmony?s pulmonary valve may come loose during placement due to a bond break.
Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. <br />
Pregnant patients should discuss test results with a health care provider before making any decisions about their pregnancy
Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargineyfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin Glargine
The U.S. Food and Drug Administration (FDA) wants to increase awareness about the intended use of imaging software for intracranial large vessel occlusion or LVO.
Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
Do not use high-level disinfection methods for reprocessing affected urological endoscopes from Karl Storz.
Best Brands Consumer Products, Inc. is voluntarily recalling two (2) finished product lots of The Mandalorian Hand Sanitizer Ethyl Alcohol 68%, available in green and blue formulations and Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% blue formulation to the consumer level.
Chatsworth, California, F&S Medical Supply, dba Pink Toyz is voluntarily recalling one lot of Pink Pussycat 3000 mg capsules to the consumer level. FDA analysis has found the product Pink Pussycat to be tainted with sildenafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in an
The FDA is recommending that newborns and children through 3 years old have follow-up thyroid monitoring within 3 weeks after receiving injections of contrast media containing iodine, also called ?contrast dye,? for X-rays and other medical imaging procedures.
3/30/2022 4:56:00 PM
Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial, to the user level in the United States. This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the prod
Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic
): Certain Point of Care Celltrion USA?s DiaTrust COVID-19 Ag Rapid Tests are being recalled because they were labeled for Research Use Only but distributed to customers for non-research, unauthorized uses are being recalled.
Sandoz Inc. (?Sandoz?) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level.
Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) is voluntarily recalling certain lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The batches in the table below are being recalled due to the potential
Certain lots of Celltrion USA?s DiaTrust COVID-19 Ag Rapid Tests are being recalled for a high number of false positives and a longer shelf life than authorized by the FDA