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Medical device recalls

Medical device recalls from FDA, newest first.
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5 recalls

Beckman Coulter Chemistry Analyzer AU480

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

Moderate risk, FDA, Software defect

4 recalls

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

1 recall

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

8 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

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 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

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

EnCor EnCompass Breast Biopsy and Tissue Removal System Console

The breast biopsy system may experience errors that interrupt or prolong the procedure.

Moderate risk, FDA, Device defect

McKesson, Alere, Fisher Scientific, and Henry Schein hCG Tests

HCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Moderate risk, FDA, Device defect

HeartSine Samaritan PAD Public Access Defibrillators

HeartSine samaritan PAD defibrillators were distributed without the required Maintenance Supplement.

Low risk, FDA, Device defect

2 recalls

Medline Convenience Kits

The kits contain neurological sponges with potential for unexpected variability of endotoxin levels.

Moderate risk, FDA, Contamination

Baxter Pro+ MRS Surfaces for VersaCare

PRO+ MRS Surface for Versacare has an error in its UDI label that may lead to incorrect product identification.

Moderate risk, FDA, Labeling error

4 recalls

AVID Medical Halyard IV Start Kits

Halyard IV Start Kit NON-Sterile may have an open or incomplete seal on the applicator packaging.

Moderate risk, FDA, Packaging defect

AVID Medical Halyard IV Start Kits

Halyard IV Start Kit NON-Sterile may be contaminated with Aspergillus penicillioides.

High risk, FDA, Contamination

Cardioroot Woven Collagen Coated Vascular Graft

The Cardioroot Woven Collagen Coated Vascular Graft failed water permeability acceptance criteria.

Moderate risk, FDA, Device defect

Imager II Angiographic Catheters

Imager II Angiographic Catheters may fracture or detach, leading to device fragments remaining or migrating.

High risk, FDA, Device defect

1 recall

NGenuity Patient Monitor with Capnography (ETCO2)

The patient monitor can show a Checkline Error alarm at setup, which may delay the procedure.

Moderate risk, FDA, Device defect

2 recalls

ForeSight Elite Tissue Oximetry Cable

The ForeSight Elite Tissue Oximetry Cable has incorrect switching of channels 1 and 2 on the module and flag labels.

Moderate risk, FDA, Labeling error

Abiomed Impella Controllers

The Automated Impella Controller has defects in firmware and software that can affect pressure signal accuracy and cause unreliable signals.

Moderate risk, FDA, Software defect

8 recalls

Philips Achieva, Ingenia, Intera and MR MRI Systems

A software issue can terminate an examination during image reconstruction if scan parameters are manually adjusted.

Moderate risk, FDA, Software defect

Philips EPIQ Elite Diagnostic Ultrasound System

The Philips EPIQ Elite ultrasound system has a software issue that can cause inaccurate blood flow measurements and misdiagnosis.

Moderate risk, FDA, Software defect

Fresenius Medical Care CombiSet Hemodialysis Blood Tubing Sets

Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

Moderate risk, FDA, Device defect

Maquet PowerLED 300 Concealed Lighting System

The PowerLED 300 Concealed Lighting System can detach at the junction between the spring arm and suspension arm and fall, causing potential injury.

Moderate risk, FDA, Device defect

SeaSpine Mariner Deformity Extended Polyaxial Head

The spinal device has a thread depth out of design specification.

Moderate risk, FDA, Device defect

CooperSurgical INCA Infant Nasal CPAP Sets

The INCA Infant Nasal CPAP Complete Set may have a loose tubing connection, causing loss of pressure and reduced oxygenation.

High risk, FDA, Device defect

Midmark IQvitals Zone

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Moderate risk, FDA, Device defect

Olympus BiCOAG Hemostasis Probe

The Olympus BiCOAG Hemostasis Probe may have a ceramic tip that can detach.

Moderate risk, FDA, Device defect

1 recall

Pi-Cardia ShortCut Device

The ShortCut transfemoral catheter has a detaching positioning arm due to a weld issue.

Moderate risk, FDA, Device defect

9 recalls

Captus 4000e Thyroid Uptake System

Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.

Moderate risk, FDA, Device defect

Abiomed Impella Controllers

The Automated Impella Controller may have purge cassette recognition issues due to a purge flag component failure.

High risk, FDA, Device defect

Medline Convenience Kits for Anesthesia, Minor Procedures, Myringotomy and Cataract Surgery

Convenience kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to contamination or patient infection.

Moderate risk, FDA, Sterility problem

Datex-Ohmeda Aisys Anesthesia Systems

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control.

Moderate risk, FDA, Device defect

Stryker Sustainability Solutions Ethicon XCEL Bladeless Trocars

Reusable access port system may crack or seperate during use.

Moderate risk, FDA, Device defect

Boston Scientific StoneSmart Connect Console

The StoneSmart Connect Console has power adapters with higher-than-expected resistance in the electrical grounding path.

Moderate risk, FDA, Device defect

Howmedica Osteonics Orthopaedic Implant Components

Orthopaedic implant components made from aged Uhmwpe may oxidize, causing wear and potential harm.

Moderate risk, FDA, Device defect

Hemospray Endoscopic Hemostat

The hemostatic device has an issue with endoscope adherence and inability to spray powder.

Moderate risk, FDA, Device defect

Embecta Nano Pro Un-Cannulated Demo Samples

Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

Moderate risk, FDA, Labeling error

5 recalls

VERIQA RT MonteCarlo 3D v3 Software

The software accounts for a bolus in a treatment plan but does not display it clearly.

Moderate risk, FDA, Software defect

Straumann GM Helix Implant

The GM Helix Implant has a discrepancy between its packaging identification and the dimensions of the implant inside.

Moderate risk, FDA, Device defect

GE Healthcare Centricity Enterprise Archive, Enterprise Archive, Centricity PACS, Centricity PACS Server, Workflow Core Services, and Core Services Hub Software

Centricity Enterprise Archive software may associate historical imaging data with the wrong patient, potentially causing misdiagnosis or delayed care.

Moderate risk, FDA, Device defect

Happiest Baby SNOO Sleep Sacks

Extra small and extra large SNOO Sleep Sacks have not been reviewed for safety and effectiveness by the FDA.

Moderate risk, FDA, Device defect

BD Alaris Pump Infusion Sets

BD Alaris Pump Infusion Sets have performance data discrepancies that may lead to inappropriate pump performance.

High risk, FDA, Device defect

2 recalls

Medline Convenience Kits

Medline Convenience Kits contain sterile applicators that may have fungal contamination, potentially causing serious infections.

High risk, FDA, Contamination

Nuclein DASH Rapid PCR Instrument

The DASH Rapid PCR Instrument has a software issue.

Moderate risk, FDA, Software defect

8 recalls

Bayer Medical Care MEDRAD Stellant FLEX Syringe Kit

The syringe kit may not be properly sterilized due to a manufacturing issue.

Moderate risk, FDA, Device defect

Maquet Percutaneous Insertion Kits and Guidewires

The packaging may not consistently maintain sterile barrier integrity.

Moderate risk, FDA, Sterility problem