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July 22, 2021 at 12:00 AM
Sodium Citrate Blood Specimen Collection Tube Conservation Strategies
July 22, 2021 at 12:00 AM
List of Medical Device recalls in 2021.
July 22, 2021 at 12:00 AM
PE-PUR sound abatement foam in certain Philips Respironics ventilators and BiPAP machines may pose health risks
July 22, 2021 at 12:00 AM
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
July 21, 2021 at 12:00 AM
The GENOSYL DS; Nitric Oxide Delivery System delivers GENOSYL (Nitric Oxide) to newborns with respiratory failure.
July 21, 2021 at 12:00 AM
List of Medical Device recalls in 2021.
July 20, 2021 at 2:00 AM
FDA is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients.
July 19, 2021 at 12:00 AM
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
July 15, 2021 at 8:31 AM
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.
July 15, 2021 at 12:00 AM
Potential concerns in MAGEC system implants may include endcap separation and need for additional biocompatibility testing.
July 15, 2021 at 12:00 AM
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.
July 14, 2021 at 12:00 AM
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
July 13, 2021 at 12:00 AM
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.
July 09, 2021 at 12:00 AM
The LeadCare tests are used to detect blood lead level but has risk of falsely low results.
July 08, 2021 at 12:00 AM
Recommendations for Precice devices due to ongoing biocompatibility evaluation.
July 07, 2021 at 12:00 AM
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
July 07, 2021 at 12:00 AM
List of Medical Device recalls in 2021.
July 02, 2021 at 12:00 AM
List of Medical Device recalls in 2021.
July 02, 2021 at 12:00 AM
Angiographic Guidewire Component is a guidewire to help place catheters into the vasculature.
July 01, 2021 at 12:00 AM
List of Medical Device recalls in 2021.
July 01, 2021 at 12:00 AM
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
July 01, 2021 at 12:00 AM
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
July 01, 2021 at 12:00 AM
The LeadCare tests are used to detect blood lead level but has risk of falsely low results.
June 30, 2021 at 8:31 AM
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.
June 30, 2021 at 12:00 AM
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.