Sodium Citrate Blood Specimen Collection Tube Conservation Strategies
PE-PUR sound abatement foam in certain Philips Respironics ventilators and BiPAP machines may pose health risks
The Continuous and Non-Continuous Ventilators are used to provide invasive and non-invasive support for people needing respiratory support or treatment for sleep disorders
The GENOSYL DS; Nitric Oxide Delivery System delivers GENOSYL (Nitric Oxide) to newborns with respiratory failure.
FDA is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients.
Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily I
The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
This Safety Communication describes the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Recommendations for patients, caregivers and health care professionals are provided.
Potential concerns in MAGEC system implants may include endcap separation and need for additional biocompatibility testing.
Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA® and AVEENO® aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and fol
Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots of sterile compounded drug products, within expiry. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.
The LeadCare tests are used to detect blood lead level but has risk of falsely low results.
Recommendations for Precice devices due to ongoing biocompatibility evaluation.
Quidel is recalling the Lyra SARS-CoV-2 Assay (M120) due to a significant risk of false negative results for patients with high virus amounts
Angiographic Guidewire Component is a guidewire to help place catheters into the vasculature.
Santo Domingo, Dominican Republic – Ardil Comercial is voluntarily recalling one lot of Limar Hand Sanitizer, packaged in 4 oz bottles to the consumer level. The hand sanitizer is being recalled because it is packaged in containers that resemble water bottles. The product poses a risk of ingestion
Teva Pharmaceuticals has initiated a voluntary recall of lot 31328962B of Topotecan Injection 4 mg/4 mL (1 mg/mL), to the retail/institutional level in the United States. This voluntary recall was initiated based on a complaint received from a pharmacy after a single glass particle was observed ins
The FDA revoked the emergency use authorizations for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction systems.
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.
Dash Xclusive is voluntarily recalling all lots of Imperia Elita Vitaccino Coffee to the consumer level. FDA analysis has found the product to contain undeclared sibutramine and fluoxetine.