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Early Alert: Cardiac Cannula Issue from Medtronic
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Early Alert: Infusion Pump Issue from Baxter
Correction Issued for the Novum IQ Large Volume Pumps, Syringe Pumps
http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-infusion-pump-issue-baxter-0
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FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis
FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis
http://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-recurrent-respiratory-papillomatosis
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PAHO publishes new update on Oropouche fever in the Americas
PAHO publishes new update on Oropouche fever in the Americas
Cristina Mitchell
14 Aug 2025
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Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products
Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products
http://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-florida-restriction-7-oh-opioid-products
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Tandem Diabetes Care Issues Voluntary Medical Device Correction for Select t:slim X2 Insulin Pumps
SAN DIEGO – August 7, 2025 – Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery.
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Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters Due to Risk of Misleading Carbon Dioxide (CO₂) Readings
Draeger recalls SafeStar, TwinStar filters due to misleading carbon dioxide waveforms, may result in unnecessary treatment, potentially causing harm or death
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Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control Method for their SmartDrive MX2+ Power Assist Device.
Max Mobility/Permobil has voluntarily expanded its recall of the SpeedControl Dial, a wired control option for the SmartDrive MX2+ Power Assist Device, due to safety and performance concerns. This voluntary action applies to all SpeedControl Dials manufactured and distributed between the dates of Ap
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DermaRite Industries Issues Voluntary Nationwide Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination
DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia.
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FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American Growers
FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American Growers
http://www.fda.gov/news-events/press-announcements/fda-commissioner-makary-usda-secretary-rollins-celebrate-proposed-modernization-orange-juice
