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Early Alert: TactiFlex Ablation Catheter Issue from Abbott
Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues
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FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025
FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware Because of Their Potential to Leach Lead into Food When Cooking
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PAHO calls for safe care for all newborns and children on World Patient Safety Day 2025
PAHO calls for safe care for all newborns and children on World Patient Safety Day 2025
Cristina Mitchell
16 Sep 2025
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Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error
mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.
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Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication
FDA alerts of risks with use of unauthorized infant monitoring devices, which have not been reviewed for safety and effectiveness.
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Do Not Use Unauthorized Devices for Measuring Blood Pressure: FDA Safety Communication
FDA alerts of risks with use of unauthorized blood pressure devices, which have not been reviewed for safety and effectiveness.
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Early Alert: Medline Kits May Contain Recalled Medtronic Cardiac Cannulas
Medline is recalling certain Medline Kits containing recalled Medtronic DLP Left Heart Vent Catheters as the catheter may not retain its shape.
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The Region of the Americas makes progress in drowning prevention, but challenges remain
The Region of the Americas makes progress in drowning prevention, but challenges remain
Oscar Reyes
15 Sep 2025
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Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure
Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.
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Insulin Pump Correction: Tandem Diabetes Care Issues Correction for Certain t:slim X2 Insulin Pumps Due to Risk for Faulty Speaker Wiring That May Cause Malfunction and Stop Insulin Delivery
t:slim X2 insulin pumps provide insulin to people with diabetes, but a speaker wiring issue may cause an error that makes the pump stop delivering insulin.
