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Update on Alert: Nephroscope Sheath Issue from Trokamed GmbH
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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FDA Roundup: March 4, 2025
FDA Roundup: March 4, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-march-4-2025
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One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are ingredients in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as
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Pacemaker Recall: Boston Scientific Corporation Recalls Accolade Pacemaker Devices Due to a Manufacturing Issue That May Lead to Early Device Replacement
Boston Scientific is recalling pacemakers due to a manufacturing issue that may cause early device replacement.
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Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist Device Due to Risk for Motor to Be Unresponsive to the User
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial used with SmartDrive MX2+ Wheelchair Power Assist system may be unresponsive to users.
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Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That Caused Additional Procedures to Reposition or Remove Implant
Tack Endovascular System is used to repair artery dissection after angioplasty but ongoing user issues led Philips to discontinue use and distribution.
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Vaporizer Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands Recall of Vaporizer Sevoflurane Maquet Filling due to Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
Vaporizers Sevoflurane Quick-Fil and Maquet Filling mix oxygen and sevoflurane for anesthesia. This sevoflurane may degrade to toxic hydrogen fluoride.
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FDA Roundup: February 28, 2025
FDA Roundup: February 28, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-february-28-2025
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Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator With An Undersized Controller Spring
ROi newborn kits include Neo-Tee T-Piece Resuscitators. The Neo-Tee may have an undersized controller spring that could affect patient breathing support.
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Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures
Olympus Guide Sheath Kits collect samples from breathing organs through an endoscope. The tip of the guide sheath may detach during a procedure.
