American Screening LLC of Shreveport, Louisiana is voluntarily recalling 153,336 units of Hand Sanitizer, containing 70% ethyl alcohol gel to the consumer level. The hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption. Ingesting hand sanitizer, whi
The FDA is reminding providers about the risk of major complications if cardiac perforation occurs during implant of leadless pacemakers
Odor-Eaters?, owned by Blistex Inc., is voluntarily recalling a total of forty-one lots of two Odor-Eaters? spray products to the consumer level due to the presence of benzene. Internal testing identified low levels of benzene contamination in specific lots of these aerosol products.
SterRx, LLC today announced the voluntary nationwide recall of approximately 240 lots within their expiry period due to equipment and process issues that could lead to a lack of sterility assurance for products intended to be sterile.
This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.
Ellume recalled its COVID-19 Home Test because they may cause false positive SARS-CoV-2 test results.
Aligned Medical Solutions is recalling its custom convenience kits due to a plunger defect of the Monoject Flush Prefilled Syringe.
The FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure has occurred most often in children.
11/2/2021 10:00:00 AM
The ROSA One 3.1 Brain Application is a device that helps position and orient instrument holders or tool guides using the ROSA One 3.1 Brain Application software.
Battery packs are used with the Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump to inflate and deflate intra-aortic balloons that support the left ventricle. The packs are relied on when AC power is not available.
atnaturals is voluntarily recalling ten manufacturing lots of artnaturals 8oz Scent Free Hand Sanitizer. FDA testing identified 8oz bottles of Scent Free Hand Sanitizer from a single manufacturing lot: G20128A, contained several impurities. Upon being contacted by the FDA, artnaturals responded imm
Aligned Medical Solutions initiated a nationwide recall of Cardinal Health?s Monoject? Flush Prefilled Saline Syringes placed into 9,378 kits. These convenience kits have been found to contain the Cardinal Health?s Monoject? Flush Prefilled Saline Syringe part # 8881570121, which has been recalled f
Merck (NYSE: MRK), known as MSD outside the United States and Canada, is voluntarily recalling one lot of CUBICIN? (daptomycin for injection) 500mg for intravenous use, Lot 934778, Exp June 2022. Because treatment with CUBICIN is likely to be initiated at a hospital or other monitored healthcare se
Cook Medical issued a global, voluntary recall of the Transseptal Needle and the Transseptal Needle with Catheter. This recall includes all unexpired lots for both of these products. The needles were recalled due to complaints of rust on the products.
Burbank, CA, Bryant Ranch Prepack is voluntarily recalling 1 lot of Methocarbamol 500mg, Tablets to the consumer level. The bottles labeled as Methocarbamol 500mg Tablets have been found to contain Methocarbamol 750mg Tablets. If a patient takes a 750mg Tablet of Methocarbamol instead of the prescri
Abbott is recalling Alinity m SARS-CoV-2 and Alinity m Resp-4-Plex AMP Kits because they may cause false positive SARS-CoV-2 results
The FDA provides updated information from our ongoing evaluation of NTM infections in patients who have had cardiothoracic surgery using heater-cooler devices.
How to optimize dose accuracy when using ENFit LDT syringes - recommendations for patients and health care providers
Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling the five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Speci
The FDA warns public and health care providers not to use needle-free devices for injection of dermal fillers.
The FDA is providing updated recommendations to help protect patient safety and reduce the risk of adverse events associated with surgical staplers.
DeRoyal Industries Recalls Procedure Packs Containing NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching
Imperative Care is recalling ZOOM 71 Reperfusion Catheter, used to remove blood clots in the brain, due to risk of breaking during use.
Medtronic recalled all remote controllers used with the MiniMed 508 and Paradigm family of insulin pumps due to potential cybersecurity risks.
Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication