BMC Medical Recalls APAP Devices Over Firmware Defect That Can Halt Therapy
The FDA classified the action as a Class I recall after the manufacturer determined that some devices may not have received a previous firmware upgrade.
Tag: recall
All
Latest
All
Latest
Medical Device Recalls Declined in Q1 2026 Amid FDA Quality System Changes
Sedgwick’s latest report shows fewer medical device recall events in Q1 2026, while sterility-related recalls drove the majority of impacted units.
All
Latest
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.
All
Latest
BMC Medical Recalls APAP Devices Over Firmware Defect That Can Halt Therapy
The FDA classified the action as a Class I recall after the manufacturer determined that some devices may not have received a previous firmware upgrade.
FDA Expands Early Alert Program for High-Risk Device Issues
The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.
Read More
3M Company Corrects Ranger Blood/Fluid Warming System
The action addresses a discrepancy between the device’s labeled and actual performance at high flow rates, which could pose a risk of patient hypothermia.
Read More
FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller
The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
Read More
Tandem Issues Correction for t:slim X2 Insulin Pumps
A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.
Read More
Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error
Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier.
Read More
Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
Read More
All
Latest
Hamilton Medical Removes Breathing Circuits Over Serious Ventilation Risk
The devices may have cracks that could lead to patient rebreathing of exhaled gases.
