The FDA will now review whether 20 Zyn nicotine pouch products "[put] you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis,” as the company claims.
The FDA will now review whether 20 Zyn nicotine pouch products “[put] you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis,” as the company claims.
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The FDA has designated Medtronic’s voluntary recall notification for specific Newport HT70 and HT70 Plus ventilators and certain related Newport service parts as a Class I recall.
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Medtronic is recalling its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula as the tube may become dislodged or move out of place if the securement flange becomes disconnected, according to the FDA.
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The FDA has issued a public health alert warning consumers not to inhale or recreationally use any flavor of nitrous oxide products being sold in canisters, tanks, or chargers in retail stores.
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Certain Smiths Medical intubation ORAL/NASAL endotracheal tubes may be smaller than expected and could result in inadequate ventilation to the patient, according to an FDA alert.
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Sentec/Percussionaire is recalling Phasitron breathing circuit kits after receiving a customer complaint that the venturi component of the kit may stop oscillating during use, resulting in patient oxygen desaturation, according to an FDA alert.
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Baxter is replacing faulty battery chargers in the Life2000 Ventilator system after identifying a defect that triggers alarms and renders the device inoperable.
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JMC5A Ni/TruAire-5 Oxygen Concentrators have been recalled due to incidents of device melting and fire during use, according to an FDA alert.
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Mercury Medical is removing certain Neo-Tee T-Piece resuscitators from where they’re used or sold after a defect in the device’s controller was found to potentially prevent proper ventilation.
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Similarities in bottle and packaging labels between unapproved nasal and FDA-approved injectable epinephrine products make it difficult to distinguish them, risking accidental injections of the nasal solution.
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The FDA has required Guillain-Barré syndrome warnings to be added to prescribing information for RSV vaccines Abrysvo and Arexvy.
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California has initiated a voluntary recall of all raw whole milk and cream from Raw Farm LLC produced between Nov 9-27 due to multiple detections of the bird flu virus in retail and bottling locations.
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Philips has issued updated use instructions for several ventilator models following an FDA Class I recall due to risks of aerosol deposits accumulating on internal flow sensors when in-line nebulizers are used.
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The FDA has issued a Class I recall for certain lots of Percussionaire’s Phasitron 5 breathing circuits.
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The FDA has updated its guidance on GE HealthCare’s EVair compressor, confirming that formaldehyde emissions are within safety limits, while previous recommendations remain in place for the EVair 03 (Jun-Air) compressor.
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Smiths Medical has issued guidance for customers on identifying and discarding affected products.
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Baxter Healthcare has issued a correction for the Life2000 ventilator due to a potential alarm failure, with a software update forthcoming to address the issue.
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Mercury Medical is recalling Neo-Tee Resuscitators due to a risk of the inline controller malfunctioning, potentially causing a loss of ventilation.
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The correction addresses potential risks of aerosol buildup on ventilator flow sensors when using in-line nebulizers.
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Sentec/Percussionaire has updated use instructions for Phasitron 5 In-Line Valve to prevent accidental misuse of expiratory port plug.
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Philips Respironics has issued a software update and revised user instructions for its Trilogy ventilators to address previously reported and new safety risks.
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Smiths Medical has issued a correction for paraPAC Plus P300 and P310 ventilators due to a faulty tidal volume knob that may cause unintended changes in ventilation.
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Gilead has recalled one lot of Veklury (remdesivir) after confirming the presence of a glass particle in a vial following a customer complaint.
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Smiths Medical has issued a recall of PneuPAC paraPAC Plus P300 and P310 ventilators due to a faulty patient outlet connector that can loosen or detach.
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