Safety Board Expresses ‘Concern’ Over AstraZeneca Vaccine Data
A Data & Safety Monitoring Board expressed concern that AstraZeneca may have included outdated information in a Phase 3 trial for its COVID-19 vaccine.
Category: Recalls & Advisories
Recalls & Advisories
Latest
Recalls & Advisories
Latest
FDA Issues Guidance on Dry Heat to Reduce N95 Mask Bioburden
The FDA says bioburden reduction systems that use dry heat can play an important role in the ongoing efforts to help address shortages of PPE masks like N95s.
Recalls & Advisories
Latest
FDA Issues Alert for Potential False Negatives for Abbott COVID-19 Test
The US FDA issued a public alert that the Abbott ID Now point-of-care test may return false negative results for COVID-19 patients.
Class I Recall for ResMed Stellar 100/150 Ventilators
According to the FDA, the sound alarm for ResMed’s Stellar 100 and Stellar 150 noninvasive/invasive ventilators may fail in certain circumstances.
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Class I Recall for Some GE Healthcare Carescape Respiratory Modules
GE Healthcare is recalling some Carescape Respiratory Modules and Airway Gas Option due to a manufacturing issue which may cause the devices to display incorrect oxygen values, according to an alert from the FDA.
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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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Centurion Medical Recalls Airway Kits Containing Teleflex ET Tubes
According to an FDA alert, Centurion Medical Products has issued a Class I Recall for its Airway Kit containing Sheridan Endotracheal Tubes, which were previously recalled by Teleflex.
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Protecting Against Malignant Pleural Effusion
New research explains how a combination of talcum and hydrogel may protect against malignant pleural effusion.
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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.
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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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