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Medical device recalls

Medical device recalls from FDA, newest first.
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2 recalls

Philips Azurion Systems

Azurion systems may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

Moderate risk, FDA, Device defect

Laerdal Compact Suction Unit 4 RTCA Version

The Laerdal Compact Suction Unit 4 RTCA version may emit electromagnetic noise beyond acceptable limits.

Moderate risk, FDA, Device defect

1 recall

Elekta Leksell GammaPlan Radionuclide RT Treatment Planning System

Leksell GammaPlan treatment planning software has an error that may cause incorrect patient location irradiation.

Moderate risk, FDA, Device defect

2 recalls

Straumann WB Impression Post Closed Tray

The impression post closed tray contains magenta caps instead of brown.

Low risk, FDA, Device defect

Medline Medical Convenience Kits

Medline medical convenience kits may have an open seal on the packaging of the applicators.

Moderate risk, FDA, Device defect

4 recalls

Trividia Health TRUE METRIX Blood Glucose Meter Owner's Booklets and Instructions

The labeling for True Metrix blood glucose meters does not adequately explain the E-5 error code, which could delay treatment.

High risk, FDA, Labeling error

Hologic Brevera Breast Biopsy System Disposable Needle

The Brevera Breast Biopsy System Disposable 9 Gauge Needle contains particulates that can be deposited into breast tissue during use.

Moderate risk, FDA, Foreign object

Medline ReNewal Reprocessed Diagnostic Catheters

Reprocessed catheters may contain small particles of residual material.

High risk, FDA, Foreign object

Medline Suction Catheter Kits and Intubation Tray

Medline Suction Catheter Kits and Intubation Tray may contain a smaller 8 Fr catheter, which can cause airway obstruction.

Moderate risk, FDA, Device defect

3 recalls

Olympus Sphincterotomes

Single Use 3-Lumen Sphincterotome V devices may deform and lose performance.

Moderate risk, FDA, Device defect

Maquet Cardiopulmonary Bubble Sensor

The Bubble Sensor has a durability issue with its connecting cable that can cause damage or loose contact.

Moderate risk, FDA, Device defect

Boston Scientific AXIOS and HOT AXIOS Stent and Delivery Systems

AXIOS Stent and Electrocautery-Enhanced Delivery Systems may have deployment and expansion issues.

High risk, FDA, Device defect

1 recall

Vortex Surgical Ophthalmic Surgical Instruments

Volk Single Use Vitrectomy Lenses may have voids in the seal of Tyvek pouches, which could lead to infection.

Moderate risk, FDA, Sterility problem

1 recall

Siemens SOMATOM X.Ceed and NAEOTOM Alpha Software Applications

CT software applications lack FDA clearance and may be removed from certain systems.

Moderate risk, FDA, Software defect

4 recalls

VITEK 2 Gram-negative Susceptibility Cards

Issue may lead to QC failure or false resistant results.

Moderate risk, FDA, Device defect

Vantive Prismaflex and Oxiris Dialyzer Sets

The Prismaflex Set deaeration chamber may dislodge from the Control Unit.

Moderate risk, FDA, Device defect

Medtronic MiniMed 780G Insulin Pump

A software issue may cause Pump Error 43 or 41, suspending insulin delivery.

Moderate risk, FDA, Software defect

Tornier Perform Reversed Perip Screw

Screws labeled 5.0mmx18mm are actually 5.00mmx14mm, which may cause a delay or increase risk of failure.

Moderate risk, FDA, Labeling error

2 recalls

Beckman Coulter DxH Diluent and DxH ECO Diluent

Coulter DxH Diluent and ECO Diluent can cause elevated platelet background counts with use.

Moderate risk, FDA, Device defect

Olympus Single Use Electrosurgical Knives KD-640L and KD-645

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Moderate risk, FDA, Device defect

3 recalls

Broselow Pediatric Emergency Tape and Organizers

Broselow Pediatric Emergency Tape and Organizers contain potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

High risk, FDA, Device defect

Medline Medical Procedure Convenience Kits

Medline medical procedure convenience kits contain a liquid adhesive whose tubing can crack during actuation.

Moderate risk, FDA, Device defect

Cardinal Health Chest Drainage Units and Accessories

Chest drainage units may not show tidaling or bubbling when used on infants, which could lead to inadequate treatment.

Moderate risk, FDA, Device defect

1 recall

Canon Alphenix Interventional Fluoroscopic X-Ray Systems

As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed.

Moderate risk, FDA, Device defect

2 recalls

Community Products Rifton Equipment TRAM and E-Pacer Powered Lifts

The TRAM and E-Pacer have a potential for fraying on the body support strap.

Moderate risk, FDA, Device defect

Philips Patient Information Center iX

The Patient Information Center iX software can modify event notification settings without user indication.

Moderate risk, FDA, Software defect

3 recalls

Beckman Coulter LDL-Cholesterol Assay

Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU).

Moderate risk, FDA, Device defect

Sysmex America TS-10/TS-10H Tube Sorter

The TS-10/TS-10H Tube Sorter may unexpectedly disengage its lift, causing unintended downward movement.

Moderate risk, FDA, Device defect

Intuitive Surgical Ion Endoluminal System Vision Probe Bags

The Ion Vision Probe Bag may have a compromised or incomplete sterile pouch seal.

Moderate risk, FDA, Sterility problem

6 recalls

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

4 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

4 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

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

1 recall

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

1 recall

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

1 recall

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

6 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

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