Laboratories should expect some false negative results because the SARS-CoV-2 virus can mutate over time and not be detected.
The 7FR PTD Kits are used to remove clots in adult patients who have arterio-venous (AV) fistulas and synthetic dialysis grafts.
The FDA is providing updated information about a late mortality signal in patients treated for peripheral artery disease (PAD) in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents. This communication updates the January 17 and March 15, 2019 notifications.
Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injectio
Recommendations for Precice devices due to ongoing biocompatibility evaluation.
The FDA is updating recommendations for NuVasive titanium-based Precice devices.
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR. The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter,
The Procter & Gamble Company is voluntarily recalling all lots with expiry through September 2023 of specific Old Spice and Secret aerosol spray antiperspirants and Old Spice Below Deck aerosol spray products sold in the United States due to the presence of benzene
Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of four lots of Levetiracetam Injection, USP, to the user level. The lack of container closure integrity, found in reserve sample vials may result in a non-sterile product
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
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.
The FDA is reminding providers about the risk of major complications if cardiac perforation occurs during implant of leadless pacemakers
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.
Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall
This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.
The recall is due to issues with PE-PUR foam, used to reduce sound and vibration, breaking down and potentially entering the device’s air pathway.
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.
Recommendations for health care providers and facilities in treating patients who require ventilation assistance due to COVID-19 complications
FDA recognizes that the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak.