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.

2018-08-22FDA-DeviceRichard-Allan Scientific CompanyClass III
EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.
Mislabeled product
2018-08-22FDA-DeviceSiemens Medical Solutions USA, IncClass II
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body ra
Potential hardware issue which may cause thermal effects and possible damage to system parts.
2018-08-22FDA-DeviceSiemens Medical Solutions USA, IncClass II
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, mul
Potential hardware issue which may cause thermal effects and possible damage to system parts.
2018-08-22FDA-DeviceMevion Medical Systems, Inc.Class II
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
2018-08-22FDA-DeviceTosoh Bioscience IncClass II
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.
2018-08-22FDA-DeviceConvaTec, IncClass II
AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra- abdominal bladder pressure. The device attaches directly to the patient s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into t
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
2018-08-22FDA-DeviceApollo Endosurgery IncClass II
Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food consumption. The band can be inflated or deflated with saline, through the access port, dependin
Component of the Lap-Band system was missing from the package
2018-08-22FDA-DeviceMerit Medical Systems, Inc.Class II
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Supplier manufacturing defect with the syringe plunger tip.
2018-08-22FDA-DeviceSpacelabs Healthcare, Ltd.Class I
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anest
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
2018-08-15FDA-DeviceBeaver VisitecClass II
Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
2018-08-15FDA-DeviceVitalgo Inc.Class II
VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003
Potential for unintentional movement of the support surface of the bed from tilted position to horizontal position or any position in between.
2018-08-15FDA-DeviceDatex-Ohmeda, Inc.Class II
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
2018-08-15FDA-DeviceNatus Neurology DBA Excel Tech., Ltd. (XLTEK)Class II
Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.
Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may cause the cart s video pole to fail.
2018-08-15FDA-DeviceHudson Scientific LLCClass II
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding electric shocks received when using the device.
2018-08-15FDA-DeviceBoston Scientific CorporationClass II
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combinati
Potential polymer material degradation.
2018-08-15FDA-DeviceWater Pik, Inc.Class II
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns.
2018-08-15FDA-DeviceINO therapeutics LLC/dba ikariaClass II
Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the INOmeter: The INOmeter is affixed on top of each INOflo cylinder valve in Japan. When the healthcare provider opens the INOmeter the compressed gas cylinder valve opens to begin flo
INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). For Lot 17FP-0570, the label affixed to each INOflo cylinder has the correct expiration date noted (11/2020).
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
radial stem implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
rHead, Radial Implant 6 mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
radial stem implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
rHead, Radial Implant 6 mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
radial head implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
radial head implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
radial head implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
2018-08-15FDA-DeviceHowmedica Osteonics Corp.Class II
#4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

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