Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 26 - 50 of 123 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7) There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.	FDA Z-3083-2026	Medical Device	High	Sep 9, 2026 Recall: Aug 6, 2026	Details
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8) There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.	FDA Z-3081-2026	Medical Device	High	Sep 9, 2026 Recall: Aug 6, 2026	Details
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209 Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.	FDA Z-3036-2026	Medical Device	High	Sep 2, 2026 Recall: Jul 20, 2026	Details
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225 Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.	FDA Z-3039-2026	Medical Device	High	Sep 2, 2026 Recall: Jul 20, 2026	Details
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592 Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.	FDA Z-3037-2026	Medical Device	High	Sep 2, 2026 Recall: Jul 20, 2026	Details
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353 Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.	FDA Z-3038-2026	Medical Device	High	Sep 2, 2026 Recall: Jul 20, 2026	Details
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.	FDA Z-2937-2026	Medical Device	High	Aug 19, 2026 Recall: May 18, 2026	Details
Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102. Xhibit offers remote surveillance of patient data for those patients connected to a Spacelabs Healthcare bedside monitors and telemetry systems. The DisplayPort audio/video splitter allows users to extend the audio/video source from the Xhibit to additional external displays or monitors. This extension of audio/video is for viewing only and does not allow interaction with the Xhibit. Component: T Due to off-the-shelf display port component that has audio/video failures	FDA Z-2916-2026	Medical Device	High	Aug 19, 2026 Recall: Jun 4, 2026	Details
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).	FDA Z-2878-2026	Medical Device	High	Aug 12, 2026 Recall: Jul 10, 2026	Details
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color. Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.	FDA Z-2761-2026	Medical Device	High	Jul 29, 2026 Recall: Jul 7, 2026	Details
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.	FDA Z-2793-2026	Medical Device	High	Jul 29, 2026 Recall: May 13, 2026	Details
ARTIS icono ceiling. Model Number: 11328100. Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.	FDA Z-2648-2026	Medical Device	High	Jul 8, 2026 Recall: Jun 8, 2026	Details
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX. Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.	FDA Z-2579-2026	Medical Device	High	Jul 1, 2026 Recall: Jun 5, 2026	Details
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.	FDA Z-2523-2026	Medical Device	High	Jul 1, 2026 Recall: May 26, 2026	Details
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.	FDA Z-2522-2026	Medical Device	High	Jul 1, 2026 Recall: May 26, 2026	Details
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.	FDA Z-2574-2026	Medical Device	High	Jul 1, 2026 Recall: May 27, 2026	Details
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours. Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.	FDA Z-2514-2026	Medical Device	High	Jun 24, 2026 Recall: May 21, 2026	Details
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main Due to 11 volt Backup Battery failures.	FDA Z-2520-2026	Medical Device	High	Jun 24, 2026 Recall: May 13, 2026	Details
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any Due to 11 volt Backup Battery failures.	FDA Z-2519-2026	Medical Device	High	Jun 24, 2026 Recall: May 13, 2026	Details
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).	FDA Z-2242-2026	Medical Device	High	Jun 3, 2026 Recall: Apr 24, 2026	Details
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).	FDA Z-2243-2026	Medical Device	High	Jun 3, 2026 Recall: Apr 24, 2026	Details
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).	FDA Z-2244-2026	Medical Device	High	Jun 3, 2026 Recall: Apr 24, 2026	Details
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).	FDA Z-2245-2026	Medical Device	High	Jun 3, 2026 Recall: Apr 24, 2026	Details
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).	FDA Z-2247-2026	Medical Device	High	Jun 3, 2026 Recall: Apr 24, 2026	Details
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).	FDA Z-2246-2026	Medical Device	High	Jun 3, 2026 Recall: Apr 24, 2026	Details

Showing 26 - 50 of 123 product recalls

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Medical Device Recalls Today

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