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Medical device recalls

Medical device recalls from FDA, newest first.
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11 recalls

Mazor Robotics Mazor X Robotic Guidance System

The Mazor X robotic guidance system has software errors that can result in incorrect surgical instrument positioning during spinal surgery.

Moderate risk, FDA, Software defect

GE Healthcare Omni Legend PET Scanners

Omni Legend systems may show a streaking artifact in PET scan images.

Moderate risk, FDA, Device defect

7 recalls

Thoratec CentriMag Blood Pump and Kits

The CentriMag blood pump may not fit into the motor and may not lock securely, which could lead to stroke, embolism, or death.

Moderate risk, FDA, Foreign object

Hologic ThinPrep CytoLyt Solution Buffered Cell Wash Solution

ThinPrep CytoLyt Solution, a buffered cell wash solution, is contaminated with Parengyodontium album.

Moderate risk, FDA, Contamination

ICU Medical Plum Duo Infusion System

The Plum Duo Infusion System may fail to produce audible alarms, alerts, or feedback for touchscreen inputs.

Moderate risk, FDA, Device defect

Medtronic Abre Venous Self-Expanding Stent System

The Abre Venous Self-Expanding Stent System may have a Nitinol anomaly causing reduced stent diameter and radial force, potentially leading to migration.

Moderate risk, FDA, Device defect

Instrumentation Laboratory Coagulation Testing Reagents

The product has potential for microbial contamination.

Moderate risk, FDA, Contamination

ICU Medical Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray

Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray may have cracked syringe collars, leading to delayed or repeated blood draw or fluid leakage.

Moderate risk, FDA, Device defect

Intuitive Surgical da Vinci SP Access Port Kit

The da Vinci SP Access Port Kit may develop cracks, potentially causing a sterility breach.

Moderate risk, FDA, Sterility problem

6 recalls

C-RAD Catalyst+ Patient Positioning Devices

The Catalyst and Catalyst+ patient positioning device may show a patient as correctly positioned even when the isocenter is outside tolerance.

Moderate risk, FDA, Device defect

Philips Azurion Systems

Philips Azurion Systems R3.0 have software issues that may cause loss of X-ray and other problems.

Moderate risk, FDA, Software defect

PALACOS Bone Cement Mixing and Application Systems

Palacos bone cement may have ampoules that do not break, so the product cannot be used on the patient.

Moderate risk, FDA, Device defect

Philips Azurion Systems

Philips Azurion Systems have software issues that may cause system restarts and positional errors.

Moderate risk, FDA, Software defect

Diagnostica Stago Asserachrom HPIA Kits

Asserachrom HPIA can produce negative results due to a defect affecting every well in the impacted strip.

Moderate risk, FDA, Device defect

Medline Medical Procedure Convenience Kits

Medline medical procedure convenience kits can leak and emit vaporized saline that resembles smoke during use.

Moderate risk, FDA, Device defect

4 recalls

Philips Allura Xper FD10, FD20 and Biplane Systems

Philips Allura Xper systems may have a missing drip tray, allowing coolant to contact electrical components and cause short-circuits.

Moderate risk, FDA, Device defect

Canon Medical Vantage Galan 3T and Vantage Titan 3T MRI Systems

If a quench occurs, helium gas may not escape, and pressure in the helium vessel may rise.

Moderate risk, FDA, Device defect

Elekta MOSAIQ Oncology Information System with Particle Therapy License

The Mosaiq Oncology Information System with Particle Therapy License may deliver partial treatment twice, causing overtreatment.

Moderate risk, FDA, Foreign object

Repligen Maverick Measurement Module Spectrometer

The Maverick Measurement Module Spectrometer can have elevated laser output or unintended laser firing due to cable issues.

Moderate risk, FDA, Device defect

3 recalls

Fresenius Kabi Ivenix Infusion System LVP Software

The Ivenix Infusion System LVP Software has instructions for LVP duration programming that are emphasized in the IFU.

Moderate risk, FDA, Software defect

HANGZHOU BEVER MEDICAL DEVICES BD Ready-to-Use Hydrophilic Catheter

The BD Ready-to-Use Hydrophilic Catheter has a labeling error with an incorrect expiration date.

Moderate risk, FDA, Labeling error

Medline Kits With B. Braun IV Administration Sets

Medline kits containing B. Braun IV administration sets may have check valves that stick.

Moderate risk, FDA, Device defect

5 recalls

Medicrea IB3D Universal Implant Inserter and PL Instruments Set

Medicrea IB3D Universal Implant Inserter and PL Instruments Set may have a handle that untreads, causing inability to rotate implant.

Moderate risk, FDA, Device defect

Medtronic Vanta Clinician Programmer Application

The A71200 Vanta Clinician Programmer Application may not function as intended, potentially causing a prolonged or postponed surgical procedure.

Moderate risk, FDA, Device defect

Mobius Imaging AIRO Computed Tomography X-Ray System Pendants

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

Moderate risk, FDA, Labeling error

GE Medical Systems Israel Emission Computed Tomography Systems

Certain Nuclear Medicine systems could have been transported or relocated without adequate detector support.

Moderate risk, FDA, Device defect

Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheters

The Coyote balloon catheter may not inflate or deflate properly during use.

Moderate risk, FDA, Device defect

11 recalls

BD Pyxis ES Enterprise Server

BD Pyxis ES Enterprise Server has a software issue that may result in equipment not receiving timely updates of patient, medication, or related information.

Moderate risk, FDA, Software defect

Remote Diagnostic Technologies Philips Tempus Pro Patient Monitor and USB 2-Channel IBP Module

Philips Tempus Pro Patient Monitor measures ICP and BDR but these measurements are unvalidated, potentially leading to incorrect clinical decisions.

Moderate risk, FDA, Device defect

Sophysa Pressio 2 ICP Monitoring System

The Pressio 2 ICP Monitoring System can reboot.

Moderate risk, FDA, Device defect

Abiomed Impella 5.5 with SmartAssist S2

The Impella 5.5 with SmartAssist S2 Set is packaged in an incorrect outer box carton.

Moderate risk, FDA, Device defect

Integra LifeSciences Codman Microsensor and CereLink ICP Sensor Basic Kits

The Codman Microsensor Basic Kit may have corrosion stains on its included needle.

Moderate risk, FDA, Device defect

Securitas Arial 900 MHz Call Stations

Arial 900 MHz Call Stations may fail to transmit a low battery alert before battery failure.

Moderate risk, FDA, Software defect

Medline Hudson RCI Medium Concentration Oxygen Masks

Medline Hudson RCI Medium Concentration Oxygen Masks can have tubing disconnect, delaying patient care and causing shortness of breath.

Moderate risk, FDA, Device defect

IMRIS HFD100 Head Fixation Device

The Head Fixation Device HFD100 has a torque screw that may crack or separate, risking patient injury.

Moderate risk, FDA, Device defect

Philips Smart-Hopping 2.0 AP 1.4 GHz Patient Monitor

It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

Moderate risk, FDA, Device defect

Siemens LUMINOS Lotus Max and Luminos dRF Max

Luminos Lotus Max and Luminos dRF Max systems may have incorrect collimation when switching quickly between organ programs.

Moderate risk, FDA, Software defect

Philips Incisive CT

Philips Incisive CT may have an incomplete scan due to an unstable connection inside the floating sensor.

Moderate risk, FDA, Device defect

1 recall

Vision RT AlignRT InBore System

The AlignRT InBore system has an omission in its Instructions for Use regarding laser information.

Moderate risk, FDA, Device defect

1 recall

Beckman Coulter UniCel DxI 600 and DxI 800 Immunoassay Systems

Beckman Coulter UniCel Dxl 600 and UniCel Dxl 800 analyzers may not restart after a standard shutdown, causing delayed results.

Moderate risk, FDA, Device defect

1 recall

Meridian Bioscience Revogene C. Difficile Assay

The Revogene C. difficile assay may show a decline in performance over time, leading to false-negative results.

Moderate risk, FDA, Device defect

3 recalls

Halyard Organ Recovery OR Pack and Mini Plus Kit South

Halyard Organ Recovery OR Pack and Halyard Mini Plus Kit South are not suitable for organ transplant.

High risk, FDA, Device defect

Roche Diagnostics Elecsys Anti-TSHR Immunoassay

The Elecsys Anti-TSHR immunoassay results vary by instrument platform and calibrator lot, which may lead to delayed or incorrect diagnosis.

Moderate risk, FDA, Device defect

Applied Medical Kii Low Profile Bladed Dual Pack

Kii Low Profile, Bladed Dual Pack has a potential for extended blade obturator length after assembly.

Moderate risk, FDA, Device defect

1 recall

Abbott FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors

A manufacturing issue may cause carbon build up in the sensor, leading to incorrect low glucose results.

High risk, FDA, Device defect