Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amo
Biota Biosciences is voluntarily recalling the following lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level.
Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm.
The identified catheters are latex balloon catheters used for temporary blockage, closing of a blood vessel, or infusion of fluids. These catheters are at risk of tip detachment which could lead to pieces of the catheter breaking off. This could cause serious consequences.
MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil
ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint
3M Comply Hydrogen Peroxide Chemical Indicator 1248 and Aesculap MD334 Process Indicator Card use different colors to indicate a sterilized device.
The FDA is concerned that certain respirators from China may not provide adequate protection to health care personnel based on testing by CDC NIOSH.
Vascular Solutions, Inc. recalled the Langston Dual Lumen catheter due to the inner catheter may separate during or after a high-pressure injection.
List of Medical Device recalls in 2020.
CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1
FDA continues to work with the manufacturers to evaluate reports of deaths in patients with liquid-filled intragastric balloon systems used to treat obesity.
The FDA is issuing this update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.
The FDA has recently received multiple reports for two different types of adverse events associated with liquid-filled intragastric balloons used to treat obesity. The first type of adverse event involves balloon over-inflating and the second type is development of acute pancreatitis.
QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi
The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to health care organization during the Coronavirus Disease 2019 (COVID-19) outbreak.
An update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape liquid-filled intragastric balloons used for weight loss in adult patients with obesity.
FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease.
Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail branded packaging.
Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level.. During stability testing of Batch H8J812, test results were found to exceed the specification limits fo