Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceTP Orthodontics, Inc.Class IIJasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
- 2018-05-16FDA-DeviceOndamed IncClass IIOndamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2.
- 2018-05-16FDA-DeviceNinepoint Medical Inc.Class IINvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.
Distal tips of the probes may detach from the probe shaft during use.
- 2018-05-16FDA-DeviceMHC Medical Products LLCClass IIEasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
The retail shelf cartons may be labeled with an incorrect lot number.
- 2018-05-16FDA-DeviceMHC Medical Products LLCClass IIEasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
The retail shelf cartons may be labeled with an incorrect lot number.
- 2018-05-16FDA-DeviceSiemens Medical Solutions USA, IncClass IISyngo.Via VB20A model 1049610
Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.
- 2018-05-16FDA-DeviceParker Laboratories, Inc.Class IISterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
There is a potential for the gel packets to have leaks in the packet seal.
- 2018-05-16FDA-DeviceTransonic Systems IncClass IITransonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
- 2018-05-16FDA-DeviceICU Medical, Inc.Class IIHemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceBard Peripheral Vascular IncClass IIPOWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
- 2018-05-16FDA-DeviceSynthes (USA) Products LLCClass IIRetractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
- 2018-05-16FDA-DeviceSynthes (USA) Products LLCClass IIRetractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
- 2018-05-16FDA-DeviceTornier, IncClass IIAEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated
Drill bit tips without new BargerGard tip protector may puncture through sterile packaging.
- 2018-05-16FDA-DeviceCook Inc.Class IIConnecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
- 2018-05-16FDA-DeviceCook Inc.Class IIConnecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
- 2018-05-16FDA-DeviceCook Inc.Class IIConnecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
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