Category: Recalls

Recalls

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.

Recalls

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.

Recalls

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.

Recalls

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 Announces Class I Recall for ICU Medical Infusion Pump

Aug 29, 2025

A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.