Fresenius Kabi Issues Limited Ivenix LVP Recall
Fresenius Kabi recalled a specific lot of Ivenix LVP Primary Administration Sets due to a defect that could cause uncontrolled flow.
Category: Recalls
Recalls
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Recalls
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Baxter Recalls Life2000 Ventilator for Battery Charging Issue
Baxter is recalling the Life2000 Ventilator System due to potential battery charging dongle failure, which can prevent or hinder charging.
Recalls
Latest
SonarMed Recalls Acoustic Airway Sensors
SonarMed Airway acoustic sensors were recalled for a restricted inner diameter, causing compatibility issues with suction catheters.
Recalls
Latest
Fresenius Kabi Issues Limited Ivenix LVP Recall
Fresenius Kabi recalled a specific lot of Ivenix LVP Primary Administration Sets due to a defect that could cause uncontrolled flow.
Philips Recalls BrightView Imaging Systems
Philips has recalled its BrightView SPECT imaging systems for a potential component failure that would cause parts to fall on the patient.
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GAO to Investigate FDA’s Medical Device Oversight
The Government Accountability Office (GAO) is launching an investigation into the U.S. FDA’s potentially ineffective policies for recalling medical devices, prompted by concerns raised by Senators Durbin and Blumenthal regarding the slow response to recalls of Philips Respironics CPAPs, BiPAPs, and mechanical ventilators.
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ResMed Recalls CPAP Masks for Possible Magnetic Interference
ResMed Ltd is recalling all its CPAP masks with magnets due to possible magnetic interference with certain medical devices.
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Olympus Recalls Bronchoscopes for Burn Risk
Olympus is recalling certain bronchofiberscopes and bronchovideoscopes because they may lead to burns or catch fire.
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Senators Call for Review of ‘Ineffective’ FDA Recall Policies
Senators Durbin and Blumenthal have requested the Government Accountability Office (GAO) to review the FDA’s policies on medical device recalls, citing the Philips Respironics case and a significant increase in recalls.
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MasterControl Study Finds 115% Increase in Recalls Over 5 Years
Despite a 115% increase in FDA recalls since 2018, MasterControl found that medical devices only contributed 4% of the total number.
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Recalls
Latest
Getinge Issues Recall for Cardiohelp Emergency Drive
Getinge is recalling the Cardiohelp Emergency Drive due to a possible impairment of the ability of the emergency drive to be cranked.
