Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 3,201–3,250 of 7,959
- Class II
Medical Device Recall · May 15, 2025
Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray systemIn very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
- Class II
Medical Device Recall · May 15, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
- Class I
Medical Device Recall · May 15, 2025
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reThe impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
- Class I
Medical Device Recall · May 14, 2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterialdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
Medical Device Recall · May 14, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae providesdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
Medical Device Recall · May 14, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae providesdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
Medical Device Recall · May 14, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae providesdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
Medical Device Recall · May 14, 2025
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae providesdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
Medical Device Recall · May 14, 2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterialdue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Ingenia 1.5T CX; Model Number: 781262;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow ControllerIncorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Upgrade to MR 7700; Model Number: 782130;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Ingenia 3.0T CX; Model Number: 781271;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Ami HTX.The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
- Class II
Medical Device Recall · May 13, 2025
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow ControllerIncorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Ingenia 1.5T S; Model Number: 781347;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Lago XThe X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
- Class II
Medical Device Recall · May 13, 2025
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow ControllerIncorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
- Class II
Medical Device Recall · May 13, 2025
Allon 2001. Part Number: 200-00263An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.
- Class II
Medical Device Recall · May 13, 2025
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 13, 2025
Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
- Class II
Medical Device Recall · May 12, 2025
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
- Class I
Medical Device Recall · May 12, 2025
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
- Class II
Medical Device Recall · May 12, 2025
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
- Class II
Medical Device Recall · May 12, 2025
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
- Class I
Medical Device Recall · May 12, 2025
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
- Class I
Medical Device Recall · May 12, 2025
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
- Class I
Medical Device Recall · May 12, 2025
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
- Class I
Medical Device Recall · May 12, 2025
Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GTDefective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
- Class II
Medical Device Recall · May 12, 2025
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed MSterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
- Class II
Medical Device Recall · May 12, 2025
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINASterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
- Class II
Medical Device Recall · May 12, 2025
The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
- Class II
Medical Device Recall · May 12, 2025
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
- Class II
Medical Device Recall · May 9, 2025
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -HCathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures
- Class I
Medical Device Recall · May 9, 2025
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUSThis device does not indicate for use in patients with respiratory failure.
- Class II
Medical Device Recall · May 9, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions);a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
- Class II
Medical Device Recall · May 9, 2025
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
- Class I
Medical Device Recall · May 9, 2025
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.This device does not indicate for use in patients with respiratory failure.