Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 3,101–3,150 of 7,959
- 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 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
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 The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-RKit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia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 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 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 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 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 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
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 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 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 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
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 28, 2025
Philips S7-3t Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- 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
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder deviPackage labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- Class II
Medical Device Recall · May 28, 2025
Philips 3D9-3v Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder deviPackage labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- Class II
Medical Device Recall · May 28, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 7A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
- Class II
Medical Device Recall · May 28, 2025
Philips X8-2t Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips eL18-4 EMT 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 X6-1 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
Philips L8-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder deviPackage labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- Class II
Medical Device Recall · May 28, 2025
Philips L9-3 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
Philips eL18-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips C5-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips L12-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips V6-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder deviPackage labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
- 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 X7-2t Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips X5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- Class II
Medical Device Recall · May 28, 2025
Philips S8-3t Transducer.Ultrasound transducer devices were refurbished beyond their useful life.
- 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 L12-4 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 27, 2025
Medtronic Navigation, Inc.-Boxborough
O-arm O2 Imaging System. Mobile X-Ray System.A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
- Class II
Medical Device Recall · May 27, 2025
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
- Class II
Medical Device Recall · May 23, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- Class II
Medical Device Recall · May 23, 2025
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-5255Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.