FDA Updates Guidance for COVID-19 Noninvasive Monitoring Devices
The FDA has updated its immediately in effect guidance related to noninvasive remote monitoring devices used for COVID-19 patients.
Category: Recalls & Advisories
Recalls & Advisories
Latest
Recalls & Advisories
Latest
FDA Issues Warning Over Hydroxychloroquine, Chloroquine Side Effects
The US FDA has issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.
Recalls & Advisories
Popular
Teleflex Recalls Neonatal ConchaSmart Breathing Circuits
According to the FDA, a Class I recall has been issued for Teleflex's Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column.
Teleflex Recalls Babi.Plus Pressure Relief Manifold Used for Bubble CPAP
Teleflex Inc has issued a recall for certain lots of the GaleMed Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is most commonly used for bubble CPAP therapy.
Read MoreJuul Warned Over Claims E-Cigarette Safer Than Smoking
Federal health authorities on Monday blasted vaping company Juul for illegally pitching its electronic cigarettes as a safer alternative to smoking and ordered the company to stop making unproven claims for its products. The...
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Hamilton-G5 Ventilators Recalled
According to the FDA, a Class I recall has been issued for Hamilton Medical’s Hamilton-G5 ventilator due to due to the potential for the ventilator to stop working and enter an ambient state.
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FDA: Reports of Seizures Among E-cigarette Users
The FDA has issued a health notice indicating some users of electronic cigarettes have experienced seizures, with most reports involving youth or young adult users.
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Asbestos Found in Cosmetic Products
The FDA has issued a warning to consumers after it found asbestos in three cosmetic products sold by Claire’s Stores Inc.
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Medtronic Issues Worldwide Voluntary Field Corrective Action for PB980
Medtronic is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett 980 (PB980) ventilator series.
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Class I Recall for Airlife Resuscitation Device
Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit, according to an FDA MedWatch Alert.
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FDA Revises Safety Labels on Children’s Cough Medicine
The US FDA is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old.
Read MoreInterMune IPF Drug Gets ‘Breakthrough’ Designation from FDA
InterMune secured the FDA’s breakthrough therapy designation for its in-development treatment of idiopathic pulmonary fibrosis (IPF).
Read MoreFDA Accepts NDA Filing for Boehringer’s IPF Drug Nintedanib
Boehringer Ingelheim Pharmaceuticals Inc’s New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the FDA and granted Priority Review designation.
Read MoreFDA to Host Meeting on IPF Drug Treatment
In September, the Food and Drug Administration will host a meeting on patient-focused drug treatment of idiopathic pulmonary fibrosis (IPF), according to an announcement from the Pulmonary Fibrosis Foundation.
Read MoreFDA Cites GSK Flu Vaccine Plant for Quality Violations
A GlaxoSmithKline plant in Canada that makes the flu vaccine Flulaval has been cited by the FDA for failing to meet quality control standards.
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