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Medical device recalls

Medical device recalls from FDA, newest first.
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1 recall

MicroPort HIPTURN Fem Head Trial 36mm Reusable

The Hipturn FEM Head Trial 36MM Reusable lacks FDA premarket authorization for U.S. distribution.

Moderate risk, FDA, Device defect

7 recalls

Philips Azurion System

Issue 1 - System remains in continuous restart mode after the start-up.

Moderate risk, FDA, Software defect

ICU Medical Plum Duo and Plum Solo Infusion Pumps

ICU Medical Plum Duo and Plum Solo Infusion Pumps can prevent programming a piggyback flush, causing a violation message.

Moderate risk, FDA, Software defect

Merit Medical Inflation Devices and Custom Kits

Inflation device handle may detach from the syringe during procedure.

Moderate risk, FDA, Device defect

ICU Medical Tego Connector

The Tego Connector has a silicone seal that may bulge, separate, or tear, causing fluid leaks and therapy interruption.

Moderate risk, FDA, Contamination

Baxter SIGMA Spectrum Infusion Pump

The SIGMA Spectrum Infusion Pump has defective grease that may cause over-infusion or free-flow.

Moderate risk, FDA, Device defect

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

5 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

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

3 recalls

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

Philips Azurion Systems

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

Moderate risk, FDA, Software 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

2 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

2 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

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

2 recalls

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

7 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

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

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

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