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.
Category: Recalls
Recalls
Latest
Recalls
Latest
FDA Issues Class I Recall for Ambu Manual Resuscitators
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.
Recalls
Latest
SunMed Holdings Removes Adult Manual Resuscitator Devices
The Class I recall involves devices with incorrectly assembled B/V filters.
Recalls
Latest
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.
FDA Flags Three Infusion Pump Corrections from Smiths Medical as Class I Recalls
Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.
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Medical Device Recall Volume Hits Three-Year Low, But Class I Events Rise
While total recalls and units affected declined in Q1 2025, the number of Class I events increased.
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Smiths Medical Recalls Endotracheal Tubes Over Ventilation Risk
Devices are being removed from use after certain sizes were found to have smaller diameters than expected, potentially limiting airflow. Eight injuries have been reported.
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BD Issues Correction for Infusion Pump Software
BD is correcting software for its Alaris Systems Manager and CCE Infusion Adapter after identifying a risk that outdated infusion parameters could be uploaded, potentially leading to incorrect dosing.
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FDA Issues Early Alert on Baxter Spectrum Infusion Pump Recall
The FDA has issued an early alert regarding Baxter’s recall of certain Spectrum infusion pumps due to missing motor mounting screws, which may have occurred during servicing.
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Medical Device Recalls Reach Highest Level in Four Years
Sedgwick brand protection releases a year-in-review analysis of 2024 recall data, including the top five failures for medical devices.
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Recalls
Latest
Abiomed Updates Use Instructions for Impella RP Pumps Due to Device Interaction Risk
Abiomed has updated the use instructions for its Impella RP pumps due to a risk of device interaction that could damage the optical sensor or temporarily stop the pump.
