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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.
Author: FDA
Posted: July 29, 2021, 4:00 am
FDA warns lab staff that use of BD SARS-CoV-2 Reagents for the BD Max System may lead to false positive results.
Author: FDA
Posted: July 29, 2021, 4:00 am
Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall
Author: FDA
Posted: July 29, 2021, 4:00 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
Author: FDA
Posted: July 22, 2021, 4:00 am
PE-PUR sound abatement foam in certain Philips Respironics ventilators and BiPAP machines may pose health risks
Author: FDA
Posted: July 22, 2021, 4:00 am
List of Medical Device recalls in 2021.
Author: FDA
Posted: July 22, 2021, 4:00 am
Sodium Citrate Blood Specimen Collection Tube Conservation Strategies
Author: FDA
Posted: July 22, 2021, 4:00 am
The GENOSYL DS; Nitric Oxide Delivery System delivers GENOSYL (Nitric Oxide) to newborns with respiratory failure.
Author: FDA
Posted: July 21, 2021, 4:00 am
FDA is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients.
Author: FDA
Posted: July 20, 2021, 6:00 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
Author: FDA
Posted: July 19, 2021, 4:00 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.
Author: FDA
Posted: July 15, 2021, 12:31 pm
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.
Author: FDA
Posted: July 15, 2021, 4:00 am
Potential concerns in MAGEC system implants may include endcap separation and need for additional biocompatibility testing.
Author: FDA
Posted: July 15, 2021, 4:00 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
Author: FDA
Posted: July 14, 2021, 4:00 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.
Author: FDA
Posted: July 13, 2021, 4:00 am
The LeadCare tests are used to detect blood lead level but has risk of falsely low results.
Author: FDA
Posted: July 9, 2021, 4:00 am
Recommendations for Precice devices due to ongoing biocompatibility evaluation.
Author: FDA
Posted: July 8, 2021, 4:00 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
Author: FDA
Posted: July 7, 2021, 4:00 am
Angiographic Guidewire Component is a guidewire to help place catheters into the vasculature.
Author: FDA
Posted: July 2, 2021, 4:00 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
Author: FDA
Posted: July 1, 2021, 4:00 am