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Medical device recalls

Medical device recalls from FDA, newest first.
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10 recalls

Becton Dickinson BD Phoenix Panels NMIC-306 and NMIC-312

BD Phoenix Panel NMIC-312 may have quality control failures with Klebsiella pneumoniae.

Moderate risk, FDA, Device defect

Medtronic Grafton DBM and Grafton Plus DBM Bone Grafts

Grafton DBM and Grafton Plus DBM may cause infection if implanted.

Moderate risk, FDA, Sterility problem

JenaValve Trilogy Delivery Catheters

The JenaValve Trilogy Delivery Catheter may have sleeve liner separation that can cause difficulty or inability to deploy the heart valve device.

Moderate risk, FDA, Device defect

7 recalls

Steris HexaVue Focus Integration System

HexaVue Focus Integration System may mismatch patient information on manually printed images, causing documentation discrepancies.

Moderate risk, FDA, Software defect

LeMaitre Vascular TufTex Over-the-Wire Embolectomy Catheter

The TufTex Over-the-Wire Embolectomy Catheter can fail under pull force, causing balloon components to fail.

Moderate risk, FDA, Device defect

Mindray Patient Monitors and Telemetry Monitoring Systems

The ePM Series Patient Monitor has manual descriptions that may be insufficient or require clarification regarding alarm functions.

Low risk, FDA, Device defect

Intellijoint Navigation System and Intellijoint HIP Systems

The Intellijoint Navigation System may contain a MacBook Pro battery that can overheat and pose a fire safety risk.

Moderate risk, FDA, Device defect

Canon Medical Alphenix INFX-8000C/B5

The Alphenix INFX-8000C/B5 has bolts that may loosen, causing the tabletop to shift and misalignment.

Moderate risk, FDA, Device defect

Polymedco Sediplast

Sediplast tubes may resist insertion, causing cap ejection and blood exposure.

Moderate risk, FDA, Device defect

AVID Medical Custom Surgical Procedure Kits

Davinci Trucustom Bundle may be contaminated with a lubricant used during manufacturing.

Moderate risk, FDA, Contamination

2 recalls

Onkos Surgical My3D Personalized Pelvic Implant

My3D Personalized Pelvic Implants were inadvertently mixed up and distributed to incorrect customers.

Moderate risk, FDA, Device defect

Nihon Kohden CNS-6200 Series Central Nurse Station

The Nihon Kohden CNS-6200 Series Central Nurse Station has a cybersecurity issue that could disrupt monitoring and alarm visualization.

Moderate risk, FDA, Software defect

3 recalls

Medtronic MiniMed Flex Insulin Pumps

The MiniMed Flex insulin pump may have failed verification tests, leading to issues such as inaccurate insulin delivery.

Moderate risk, FDA, Device defect

Medline Bariatric Steel Rollators

The rollator's front fork stem bolt/wheel assembly may disconnect, causing the front wheels to detach and risk severe falls.

Moderate risk, FDA, Device defect

Stryker Sustainability Solutions Bard EP XT Decapolar Steerable Diagnostic EP Catheter

The diagnostic EP catheter may have a breached sterile barrier, which could lead to particulate embolization, infection, or thrombus.

Moderate risk, FDA, Sterility problem

10 recalls

Safeguard US Operating Battle Bandage

The compression bandage may be degraded, which may cause unwanted foreign material inside the wound, leading to infection.

Moderate risk, FDA, Foreign object

HALYARD Laparoscopy Comprehensive Pack II

Laparoscopy packs labeled as latex free contain a latex urethral catheter.

Moderate risk, FDA, Labeling error

Glypto Device, Glypto Cryo Machine

The Glypto Device and Glypto Cryo Machine lack 510(k) clearance.

Moderate risk, FDA, Unapproved product

Presource Packs Containing Medtronic Microstream Components

Presource Packs containing Medtronic Microstream Components can cause difficulty disconnecting an adapter, leading to treatment delay and unintended extubation.

Moderate risk, FDA, Device defect

Beckman Coulter DxC 500 Clinical Chemistry Analyzers

DxC 500 AU and DxC 500i analyzers have a software issue that can revert test units to default without warning, causing falsely elevated results.

Moderate risk, FDA, Software defect

DRG International Sperm Ab ELISA

Potential for false negative patient results.

Moderate risk, FDA, Device defect

Spectral CT and Spectral CT 7500 RT

Spectral CT and Spectral CT 7500 RT have software issues that may affect safety and performance.

Moderate risk, FDA, Software defect

Steris VERIFY Biological Steam Test Packs and Biological Indicators

Verify Biological/Integrator Challenge Pack may have spore population below specification, potentially showing no growth in steam sterilization monitoring.

Moderate risk, FDA, Device defect

Medical Action Industries Kit: Urinary Clean Catch 20/cs

An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

Low risk, FDA, Labeling error

ADAPTABLE Beach Chair Surgical Patient Positioner

The Adaptable Beach Chair surgical patient positioner has a manufacturing issue with an inadequate weld for the head positioning system.

Moderate risk, FDA, Manufacturing problem

9 recalls

Medline Homecare Beds and Hand Pendants

Hand pendants for Medline homecare beds can overheat, posing a fire hazard.

High risk, FDA, Device defect

VentStar Resus Neo

VentStar Resus Neo disposable breathing circuit may have cracks in the hose, which could lead to leakage or the hose falling off.

High risk, FDA, Device defect

Atellica CH Revised C-Reactive Protein (RCRP)

The potential for falsely elevated results.

Moderate risk, FDA, Device defect

Expressaire and ASP Global Disposable Tourniquet Cuffs

Disposable Tourniquet Cuffs have an incorrect expiration date, as they are labeled with a 10-year shelf life instead of the validated 5 years.

Moderate risk, FDA, Labeling error

Wright Medical Technology Charlotte Claw Screw

The screw has missing threads on the screwheads, which may prevent secure engagement with the plate.

Moderate risk, FDA, Device defect

Beckman Coulter Chemistry Analyzer AU480

When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started.

Moderate risk, FDA, Software defect

Karl Storz HOPKINS Telescopes

Hopkins telescopes have an incorrect inside packaging label for the eyepiece.

Moderate risk, FDA, Labeling error

Custom Interventional Pain Management Mastisol Skin Adhesive and Continuous Epidural Trays

Mastisol Skin Adhesive has manufacturing issues with the liquid adhesive in surgical trays.

Moderate risk, FDA, Manufacturing problem

Illumina NovaSeq 6000Dx and DRAGEN Server for NextSeq 550Dx

The NovaSeq 6000Dx and Illumina Dragen Server have a security vulnerability.

Moderate risk, FDA, Software defect

5 recalls

Philips Spectral CT 7500

The Spectral CT 7500 software may crash during bolus tracking.

Moderate risk, FDA, Device defect

Penumbra System (RED 62 Reperfusion Catheter)

The Penumbra System (RED 62 Reperfusion Catheter) may fracture due to manufacturing issues.

Moderate risk, FDA, Manufacturing problem

Tandem T:Slim Mobile Application

The t:slim iOS app has a software issue preventing pairing with CGM sensors, which could lead to hypoglycemia or hyperglycemia.

Moderate risk, FDA, Software defect

Olympus Tripp-Lite DisplayPort Cables

The DisplayPort cable may cause a video dropout or blackout in high-power mode.

Moderate risk, FDA, Device defect

Quantum PureFlow Standard Heat Exchanger

The Quantum PureFlow Standard Heat Exchanger can leak blood-to-glycol.

Moderate risk, FDA, Device defect

2 recalls

Pipeline Flex Embolization Device with Shield Technology

The Pipeline Flex Embolization Device with Shield Technology has incorrect label dimensions, being 2.50 mm instead of 3.00 mm.

Moderate risk, FDA, Labeling error

Percussionaire Intrapulmonary Percussive Ventilation and Phasitron Breathing Circuits

Labeling was updated to warn against using intrapulmonary percussive ventilation with volatile anesthetic delivery systems.

Moderate risk, FDA, Labeling error

13 recalls

Philips MRI Scanners and Upgrade Kits

Ingenia Blue Seal SE and Blue Seal XE export incorrect diffusion data when using Enhanced MR Dicom format.

Moderate risk, FDA, Software defect

NOxBOXi Nitric Oxide Delivery System

The NOxBOXi Nitric Oxide Delivery System may have irregular oxygen readings due to a manufacturing issue.

Moderate risk, FDA, Manufacturing problem

Olympus M3 Gold Autoclavable Foroblique Telescope 30 and Lateral Telescope 70

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

Moderate risk, FDA, Sterility problem

Cardinal Health 200 Presource Packs Containing Stryker StrykeFlow PS and AHTO Tube Sets

The tube sets may leak fluid during use, potentially causing a slip and fall.

Moderate risk, FDA, Device defect

American Contract Systems BD Urinary Catheter Trays

Medical convenience kits with BD CliniClean Pericare Wipes may contain contaminated wipes causing skin irritation or infection risk.

Moderate risk, FDA, Contamination

American Nitrile Blue Nitrile Patient Examination Gloves

Blue Nitrile Patient examination gloves may have tears, missing fingers, and debris, which can expose people to infectious pathogens or chemical agents.

Moderate risk, FDA, Contamination

United Imaging Computed Tomography and Positron Emission Tomography Systems

The systems have a software problem when Split or Local function is enabled and multiple RIS exams are merged into a single study.

Moderate risk, FDA, Software defect

Volcano Philips IntraSight Plus

The Philips IntraSight Plus may associate image data with another patient's record, potentially causing incorrect diagnosis or treatment.

Moderate risk, FDA, Software defect

Heraeus PALACOS Bone Cement Mixing and Application Systems

Palacos R pro bone cement has a potential for monomer liquid leakage.

Moderate risk, FDA, Device defect