Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-10-10FDA-DeviceICU Medical, Inc.Class IIICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.
- 2018-10-10FDA-DeviceSurge Medical Sales, LLC (DBA Surge Cardiovascular)Class IIRetrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
The device was built with the rigid insertion stylet instead of the flexible stylet.
- 2018-10-10FDA-DeviceHeartware, Inc.Class IIHeart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.
- 2018-10-10FDA-DeviceJohnson & Johnson Surgical Vision IncClass IIOptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is i
Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.
- 2018-10-10FDA-DeviceVision RT LtdClass IIIntegrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
- 2018-10-10FDA-DeviceLeica Microsystems, Inc.Class IILeica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user.
- 2018-10-10FDA-DeviceCincinnati Sub-Zero Products LLC, a Gentherm CompanyClass IIHemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper/hypothermia blanket under the patient to provide warming through conductive heat transfer.
Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.
- 2018-10-10FDA-DeviceDannoritzer Medizintechnik GmbH & Co. KGClass IIILaparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.
- 2018-10-10FDA-DeviceOrtho Clinical Diagnostics IncClass IIVITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
- 2018-10-10FDA-DeviceOrtho Clinical Diagnostics IncClass IIVITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
- 2018-10-10FDA-DeviceOrtho Clinical Diagnostics IncClass IIVITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
- 2018-10-10FDA-DeviceOrtho Clinical Diagnostics IncClass IIVITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (INTL) M REFURBISHED, CS78654
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (INTL) N REFURBISHED, CS78652
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 N CYVITAL, CS08799
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 N W/PRINTER CYVITAL, CS08798
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 M W/PRINTER CYVITAL, CS08796
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (INTL) M W/PRINTER, CS08660
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 M NICU (CPM), CS08654RN
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 M ADULT ICU (CPM), CS08654RA
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICapnostream20 (INTL) M, CS08654
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
- 2018-10-10FDA-DeviceOridion Medical 1987 Ltd.Class IICAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
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