Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-03-11FDA-DeviceCovidien LlcClass IICovidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
- 2020-03-11FDA-DeviceStryker CorporationClass IIStryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court, San Jose, CA 95138, UDI: 07613327462784 - Product Usage: The Connect OR Cart is a mobile, medical-grade cart intended to store and transport components of minimally invasive and open-field imaging systems such as the Stryker Advanced Imaging Modality (AIM) System, PINPOINT Endoscopic Fluorescence Imaging System, or SPY Portable Handled Imaging (SPY-PHI) System) during intraoperat
There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to specifications and is positioned on the incorrect side that may lead to monitor falling from the monitor arm and a risk of user injury.
- 2020-03-11FDA-DeviceRoche Diagnostics Operations, Inc.Class IIElecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.
- 2020-03-11FDA-DeviceRESPIRATORY THERAPEUTICS GROUP LLCClass IIRespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.
It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.
- 2020-03-11FDA-DeviceAdvanced Bionics, LLCClass IIISoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics cochlear implants, a device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve.
The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.
- 2020-03-11FDA-DeviceInvivo CorporationClass IIMonitor for the Functional Imaging System for Magnetic Resonance Imaging System
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
- 2020-03-11FDA-DeviceVyaire MedicalClass IIbellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the blower. Oxygen enters through a high pressure inlet. An electronic mixer valve provides for the operator-set concentration. Gas is supplied to the patient via the microprocessor c
The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a 'no alarm' condition, or presence of non-responsive touch screen.
- 2020-03-11FDA-DevicePolymer Technology Systems, Inc.Class IIPTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
- 2020-03-11FDA-DeviceOrgan Recovery Systems, Inc.Class IILKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
- 2020-03-11FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
- 2020-03-11FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Humidity packs maintain reagent compartment humidity between 70100%. The operator loads 7 empty humidity packs initially.
A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
- 2020-03-11FDA-DeviceBard Peripheral Vascular IncClass IIBard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
- 2020-03-11FDA-DeviceBard Peripheral Vascular IncClass IIBard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
- 2020-03-11FDA-DeviceBard Peripheral Vascular IncClass IIBard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
- 2020-03-11FDA-DeviceBard Peripheral Vascular IncClass IIBard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
- 2020-03-11FDA-DeviceNormand-Info S.A.S.U.Class IIRemisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
A patch was released for a critical remote code execution vulnerability in remote desktop services. This vulnerability can be exploited remotely without authentication on certain operating systems. An attacker who successfully exploited this vulnerability could execute arbitrary code on the target system; then install programs; view, change, or delete data; or create new accounts with full user rights. If the vulnerability could be exploited locally, it would lock down the computer.
- 2020-03-11FDA-DeviceSecaClass IISeca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
It has been determined that the wheels on the baby scale cart can unexpectedly loosen and in the worst case, detach from the cart completely. If this occurs the cart can become unstable and tip over, potentially leading to the scale falling from the cart. If a baby is left unattended in a cart, the baby could fall off the scale and be subjected to several serious injuries.
- 2020-03-11FDA-DeviceBeckman Coulter IncClass IITotal Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 tests/cartridge)
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
- 2020-03-11FDA-DeviceBeckman Coulter IncClass IIDirect Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
- 2020-03-11FDA-DeviceBeckman Coulter IncClass IIUric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
- 2020-03-11FDA-DeviceBeckman Coulter IncClass IITriglycerides Reagent (TG 2 x 300), REF: 445850, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233228
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
- 2020-03-11FDA-DeviceBeckman Coulter IncClass IIEnzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
- 2020-03-11FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.
- 2020-03-11FDA-DeviceTosoh Bioscience IncClass IIAIA-360 Automated Immunoassay Analyzer, Product Code 019945
A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the instrument to stop. As a result, the run is aborted and the results are not retrievable.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
- 2020-03-11FDA-DeviceDeroyal Industries, Inc. LafolletteClass IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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