FDA: ‘Carefully Monitor’ Philips CPAP Device for Overheating
The FDA received over 270 reports related to thermal issues such as fire, smoke, burns, and other signs of overheating while patients are using Philips DreamStation 2 CPAP machines.
Category: Recalls & Advisories
Recalls & Advisories
Latest
Recalls & Advisories
Latest
Philips Recalls Certain Ventilators Over Power Management Part Concerns
The ventilators contain power management printed circuit board assemblies that were distributed by a third-party warehouse and do not meet ventilator standards, per a safety communication.
Recalls & Advisories
Latest
Philips Reaches Settlement Over Respiratory Device Recall
Philips has reached an agreement to resolve all economic loss claims related to Philips Respironics’ recall of certain respiratory care and sleep devices.
Draeger Recalls Oxylog 3000 Ventilator
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
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Cipla Recalls Six Batches of Albuterol Sulfate
The recall is due to a container defect that may result in failure to deliver the recommended dose.
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FDA Alerts Health Care Providers on Oxygenator Device Recall
The FDA is providing information on oxygenator devices used in extracorporeal circulation following a recall notice by Getinge/Maquet.
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Dräger Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits
Draeger Medical is recalling the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits after finding that glued connections may loosen before or during ventilation due to a manufacturing error.
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FDA Warns Not to Use Certain SD Biosensor COVID-19 At-Home Tests
Approximately 500,000 tests—which the FDA has “significant concerns” of bacterial contamination—were distributed to CVS Health, as well as about 16,000 tests to Amazon.
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FDA Warns Consumers Over Ammonia in “Alertness” Products
The US FDA is warning consumers to not purchase certain “alertness” and “energy boost” products, due to concerns they contain ammonia.
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FDA Updates Recommendations for N95 Respirator with Risk of Protection Failure
The recommendations come in response to questions about existing inventory the FDA says it has received from healthcare provider organizations that rely upon O&M Halyard surgical N95 respirators.
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FDA Warns of Failure Risk in Certain Masks and Respirators
The FDA says it has been made aware of laboratory test results that show certain models of surgical N95 respirators, surgical masks, and pediatric face masks do not meet quality and performance expectations and may not provide expected fluid barrier protection to the wearer.
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Philips Recalls Certain Reworked DreamStation CPAP, BiPAP Machines
The recall pertains to certain reworked DreamStations that also were recalled in June 2021.
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FDA Includes Myocarditis and Pericarditis Warning for Janssen COVID Vaccine
The revision states that the vaccine can cause thrombosis with thrombocytopenia syndrome, which may be life-threatening.
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Baxter Issues Device Correction for Life2000 Ventilator
Patient oxygen desaturation events can occur when the Life2000 ventilation system is connected with a third-party oxygen concentrator, the FDA says.
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FDA Shuts Down Two Vuse Menthol E-cigarettes
The FDA issued marketing denial orders for two Vuse menthol e-cigarette products: the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.
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