Tag: FDA recall

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FDA Issues Alert for Aligned Medical Solutions Angiographic Syringe Kits

The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.

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FDA Flags Recall Involving IMRIS MRI Systems Linked to Siemens 3T Magnet Issue

The recall affects IMPRIS Neuro III-SV models that use Siemens 3T magnets, citing a risk of blocked helium venting during a magnet quench.

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FDA Issues Recall Alert for B Braun Medical Hemodialysis Blood Tubing Set

The alert follows reports of damaged patient connectors that could introduce micro-air bubbles, trigger air-in-line alarms, and lead to treatment delays or blood loss during hemodialysis.

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FDA Issues Alert for Aligned Medical Solutions Angiographic Syringe Kits

The recall involves convenience kits containing syringes that may disconnect during use, posing risks of blood loss and air embolism.

Hamilton Medical Removes Breathing Circuits Over Serious Ventilation Risk

Aug 29, 2025

The devices may have cracks that could lead to patient rebreathing of exhaled gases.

FDA Issues Class I Recall for Ambu Manual Resuscitators

Aug 29, 2025

The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.

FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Aug 6, 2025

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

Philips Respironics Updates Use Instructions for Certain BiPAP Devices

Aug 5, 2025

Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.

Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks

Jul 23, 2025

A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.

FDA Issues Early Alert on Infusion Pump Issue from Baxter

Jul 22, 2025

The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.

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GE HealthCare Recalls Certain Carestation Devices Over Ventilation Risk

The Carestation anesthesia systems are being recalled due to a risk of ineffective ventilation in volume control mode, which could lead to serious injury or death.