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<title>MedWatch Safety Alerts RSS Feed</title>
<link>http://www.fda.gov/</link>
<description/>
<language>en</language>
<item>
<title>EnShiShiXiangNiShangMaoYouXianGongSi Issues Voluntary Nationwide Recall of ENDURANCE BOOST WITH HORNY GOAT WEED Capsules Due To Presence of Undeclared Propoxyphenylsildenafil and Sildenafil</title>
<link>http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enshishixiangnishangmaoyouxiangongsi-issues-voluntary-nationwide-recall-endurance-boost-horny-goat</link>
<description>EnShiShiXiangNiShangMaoYouXianGongSi is voluntarily recalling one lot of ENDURANCE BOOST WITH HORNY GOAT WEED (20 Count)</description>
<pubDate>Tue, 06 May 2025 12:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enshishixiangnishangmaoyouxiangongsi-issues-voluntary-nationwide-recall-endurance-boost-horny-goat</guid>
</item>
<item>
<title>Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/heart-pump-accessory-removal-abbott-removes-heartmate-mobile-power-unit-due-instances-sudden-power</link>
<description>Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss<br>
<br>
</description>
<pubDate>Thu, 24 Apr 2025 14:20:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/heart-pump-accessory-removal-abbott-removes-heartmate-mobile-power-unit-due-instances-sudden-power</guid>
</item>
<item>
<title>Risk of False Positive Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication</title>
<link>http://www.fda.gov/medical-devices/safety-communications/risk-false-positive-results-certain-capillary-blood-collection-tubes-used-magellan-diagnostics</link>
<description>FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.</description>
<pubDate>Thu, 24 Apr 2025 12:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/safety-communications/risk-false-positive-results-certain-capillary-blood-collection-tubes-used-magellan-diagnostics</guid>
</item>
<item>
<title>Early Alert: Intravascular PICC Catheter Issue from BD</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-intravascular-picc-catheter-issue-bd</link>
<description>This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program</description>
<pubDate>Fri, 18 Apr 2025 12:52:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-intravascular-picc-catheter-issue-bd</guid>
</item>
<item>
<title>Early Alert: Diagnostic Intravascular Catheter Issue from Conavi</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-diagnostic-intravascular-catheter-issue-conavi</link>
<description>This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program</description>
<pubDate>Fri, 18 Apr 2025 10:25:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-diagnostic-intravascular-catheter-issue-conavi</guid>
</item>
<item>
<title>FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I</title>
<link>http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072</link>
<description>On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product</description>
<pubDate>Fri, 18 Apr 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072</guid>
</item>
<item>
<title>Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter</title>
<link>http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp</link>
<description>Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag. <br>
</description>
<pubDate>Fri, 18 Apr 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp</guid>
</item>
<item>
<title>Max Mobility / Permobil Expands Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User</title>
<link>http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-expands-nationwide-recall-smartdrive-speed-control-dial-due-motor-being</link>
<description>Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled product that may hav</description>
<pubDate>Mon, 07 Apr 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-expands-nationwide-recall-smartdrive-speed-control-dial-due-motor-being</guid>
</item>
<item>
<title>Bausch + Lomb Announces Voluntary Recall of enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal Intraocular Lenses in the U.S.</title>
<link>http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar</link>
<description>Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced a voluntary recall of intraocular lenses (IOLs) on its enVista platform.</description>
<pubDate>Mon, 07 Apr 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bausch-lomb-announces-voluntary-recall-envista-aspiretm-envista-envytm-and-certain-envistar</guid>
</item>
<item>
<title>Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/peritoneal-dialysis-set-correction-baxter-issues-correction-minicap-extended-life-peritoneal</link>
<description>Use of Baxter MiniCap Extended Life PD Transfer Sets during peritoneal dialysis may expose patients to higher than allowable NDL-PCBAs.</description>
<pubDate>Mon, 31 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/peritoneal-dialysis-set-correction-baxter-issues-correction-minicap-extended-life-peritoneal</guid>
</item>
<item>
<title>Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems - Letter to Health Care Providers</title>
<link>http://www.fda.gov/medical-devices/letters-health-care-providers/update-potential-risk-exposure-toxic-compounds-when-using-hemodialysis-and-peritoneal-dialysis</link>
<description>The FDA expanded its evaluation of the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems</description>
<pubDate>Mon, 31 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/letters-health-care-providers/update-potential-risk-exposure-toxic-compounds-when-using-hemodialysis-and-peritoneal-dialysis</guid>
</item>
<item>
<title>Vascular Cannula Recall: Medtronic Removes Aortic Root Cannula Due to Unexpected Loose Material in the Male Luer</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/vascular-cannula-recall-medtronic-removes-aortic-root-cannula-due-unexpected-loose-material-male</link>
<description>Aortic Root Cannulas are used during heart surgery. There is a risk of extra material in the device due to a manufacturing error.</description>
<pubDate>Mon, 31 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/vascular-cannula-recall-medtronic-removes-aortic-root-cannula-due-unexpected-loose-material-male</guid>
</item>
<item>
<title>Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers</title>
<link>http://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-megadyne-mega-2000-and-mega-soft-patient-return-electrodes-letter-health-care-providers</link>
<description>Read the FDA’s recommendations related to four recalls of Megadyne Mega 2000 and Mega Soft patient return electrodes for patient burn injuries.</description>
<pubDate>Wed, 26 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-megadyne-mega-2000-and-mega-soft-patient-return-electrodes-letter-health-care-providers</guid>
</item>
<item>
<title>Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/megadyne-medical-products-inc-recalls-mega-soft-universal-patient-return-electrode-due-reports</link>
<description>Megadyne is updating the instructions and product labeling to reflect that the Mega Soft Universal pads should not be used in patients under 12 years old.</description>
<pubDate>Wed, 26 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/megadyne-medical-products-inc-recalls-mega-soft-universal-patient-return-electrode-due-reports</guid>
</item>
<item>
<title>Endotracheal Tube Recall: Smiths Medical Removes Intubation ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation </title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/endotracheal-tube-recall-smiths-medical-removes-intubation-oralnasal-endotracheal-tubes-due-smaller</link>
<description>ORAL/NASAL Endotracheal Tubes keep air flowing through a patient’s airway, but some tubes may be smaller in diameter than expected. </description>
<pubDate>Tue, 25 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/endotracheal-tube-recall-smiths-medical-removes-intubation-oralnasal-endotracheal-tubes-due-smaller</guid>
</item>
<item>
<title>Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-software-correction-becton-dickinson-and-company-bd-issues-correction-bd-alaris</link>
<description>Software from Alaris System Manager and CCE Infusion Adapter needs updates so outdated infusion information does not load to the Alaris infusion pump system. </description>
<pubDate>Thu, 20 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-software-correction-becton-dickinson-and-company-bd-issues-correction-bd-alaris</guid>
</item>
<item>
<title>Update on Alert: Infusion Pump Issue from Baxter Healthcare Corporation</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/update-alert-infusion-pump-issue-baxter-healthcare-corporation</link>
<description>This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program</description>
<pubDate>Thu, 20 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/update-alert-infusion-pump-issue-baxter-healthcare-corporation</guid>
</item>
<item>
<title>Early Alert: Aspiration System Issue from Calyxo</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-aspiration-system-issue-calyxo</link>
<description>This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program</description>
<pubDate>Thu, 20 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-aspiration-system-issue-calyxo</guid>
</item>
<item>
<title>Update on Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular</title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/update-alert-atherectomy-catheter-system-issue-bard-peripheral-vascular</link>
<description>This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program</description>
<pubDate>Thu, 20 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/update-alert-atherectomy-catheter-system-issue-bard-peripheral-vascular</guid>
</item>
<item>
<title>Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation </title>
<link>http://www.fda.gov/medical-devices/medical-device-recalls/implantable-port-recall-smiths-medical-removes-proport-plastic-implantable-ports-due-manufacturing</link>
<description>A manufacturing error may cause ProPort Plastic Implantable Ports, which are used in patients who need repeat venous access for treatment, to separate before, during, or after implantation. </description>
<pubDate>Wed, 19 Mar 2025 00:00:00 EDT</pubDate>
<dc:creator>FDA</dc:creator>
<guid isPermaLink="true">http://www.fda.gov/medical-devices/medical-device-recalls/implantable-port-recall-smiths-medical-removes-proport-plastic-implantable-ports-due-manufacturing</guid>
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