Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 3,801–3,850 of 8,689
- Class II
Medical Device Recall · June 5, 2025
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous accesDue to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
- Class II
Medical Device Recall · June 5, 2025
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous accDue to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
- Class II
Medical Device Recall · June 4, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i SETpoint CalibratorProducts have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- Class III
Medical Device Recall · June 4, 2025
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISAAn incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
- Class II
Medical Device Recall · June 4, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20. Fluoroscopic X-Ray System.Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
- Class II
Medical Device Recall · June 4, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- Class II
Medical Device Recall · June 4, 2025
Siemens Medical Solutions USA, Inc
UROSKOP Omnia. Model Number: 10094910A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- Class III
Medical Device Recall · June 4, 2025
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
- Class II
Medical Device Recall · June 4, 2025
Siemens Medical Solutions USA, Inc
UROSKOP Omnia Max. Model Number: 10762473A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- Class II
Medical Device Recall · June 4, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- Class II
Medical Device Recall · June 4, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- Class I
Medical Device Recall · June 3, 2025
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
- Class I
Medical Device Recall · June 3, 2025
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optA mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
- Class II
Medical Device Recall · June 3, 2025
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120Cather packaging may contain the incorrect French size.
- Class II
Medical Device Recall · June 3, 2025
Becton, Dickinson and Company, BD Bio Sciences
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
- Class II
Medical Device Recall · June 3, 2025
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316Cather packaging may contain the incorrect French size.
- Class II
Medical Device Recall · June 3, 2025
REF: 123400,Bard Urologist's Tray, For the Obstructed UrethraCather packaging may contain the incorrect French size.
- Class II
Medical Device Recall · June 3, 2025
Becton, Dickinson and Company, BD Bio Sciences
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
- Class II
Medical Device Recall · June 3, 2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
- Class II
Medical Device Recall · June 2, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices aDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
- Class II
Medical Device Recall · June 2, 2025
Medshape Universal Joints, REF: DNE-9000-UJBone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
- Class II
Medical Device Recall · June 2, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices aDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
- Class I
Medical Device Recall · May 30, 2025
Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - ProductThe Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
- Class I
Medical Device Recall · May 30, 2025
Servo-u Ventilator System. Model Number: 6688600.Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
- Class I
Medical Device Recall · May 30, 2025
Servo-u MR Ventilator System. Model Number: 6888800.Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
- Class I
Medical Device Recall · May 30, 2025
Servo-n Ventilator System. Model Number: 6694800.Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
- Class II
Medical Device Recall · May 30, 2025
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to ToxopDue to a risk of false positive results that could lead to unnecessary medical treatment.
- Class I
Medical Device Recall · May 30, 2025
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044;The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
- Class II
Medical Device Recall · May 30, 2025
Remote Diagnostic Technologies Ltd.
Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-RKit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
- Class II
Medical Device Recall · May 29, 2025
Intera 1.5T Achieva Nova Product Number: 781172;identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
- Class II
Medical Device Recall · May 29, 2025
Spectral CT. Computed tomography X-ray system.Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
- Class II
Medical Device Recall · May 29, 2025
Intera 1.5T Omni/Stellar; Product Number: 781104;identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
- Class II
Medical Device Recall · May 29, 2025
Intera 1.5T Achieva Nova-Dual Product Number: 781173;identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
- Class II
Medical Device Recall · May 29, 2025
Intera Achieva 1.5T Pulsar; Product Number: 781171;identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
- Class II
Medical Device Recall · May 29, 2025
Intera 1.5T Master/Nova Product Number: 781106;identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
- Class II
Medical Device Recall · May 29, 2025
Achieva XR Product Numbers: (1) 781153, (2) 781253;identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
- Class II
Medical Device Recall · May 29, 2025
Intera 1.5T Achieva IT Nova Product Number: 781175identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
- Class II
Medical Device Recall · May 29, 2025
SmartPath to dStream for 1.5T¿; Product Number: 782146;identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
- Class II
Medical Device Recall · May 29, 2025
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
- Class II
Medical Device Recall · May 29, 2025
Intera 1.5T Explorer/Nova Dual Product Number: 781108;identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
- Class II
Medical Device Recall · May 28, 2025
Philips eL18-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips S7-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips VL13-5 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips S5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips XL14-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips C9-5EC Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Terumo Cardiovascular Systems Corporation
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial KitDue to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.
- Class II
Medical Device Recall · May 28, 2025
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
- Class II
Medical Device Recall · May 28, 2025
Philips C5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips L9-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.