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Medical device recalls

Medical device recalls from FDA, newest first.
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13 recalls

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

Merit Medical Embosphere Microspheres

Embosphere syringes may have holes in packaging that could affect the sterile barrier and lead to infection.

Moderate risk, FDA, Sterility problem

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

6 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

New York Embroidery Studio Trinity Non-Surgical Isolation Gown

The isolation gowns may not meet liquid-barrier performance requirements.

Moderate risk, FDA, Device defect

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

Baxter Volara System

Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate.

Moderate risk, FDA, Contamination

3 recalls

DeRoyal Myocardial Probe 400 Series

Myocardial temperature probes contain an incorrect needle, an 18mm needle instead of a 15mm needle.

Moderate risk, FDA, Device defect

Cardinal Health 200 Presource Convenience Kits

Presource Convenience Kits contain applicators with open or incomplete seals, which could cause infection.

Moderate risk, FDA, Contamination

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

14 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

Pearle Vision 1 day (Somofilcon A) Contact Lens

Some Pearle Vision 1 day contact lenses have the incorrect power.

Moderate risk, FDA, Device defect

bioMérieux VITEK 2 AST-N461 Test Kit

The Vitek 2 AST-N461 test kit may cause false resistant results due to card pouch damage.

Moderate risk, FDA, Device defect

Medline Convenience Kits Containing Healthmark Instrument Channel Brushes

Medline convenience kits contain brushes with a sharp edge that can cut and infect.

Moderate risk, FDA, Device 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

HomeFill Oxygen Cylinders

Oxygen cylinders lack required medical gas labeling.

Moderate risk, FDA, Labeling error

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 EZDilate Endoscopic Balloon Dilators

The Olympus EZDilate Endoscopic Balloon Dilator may have an incorrect inflation chart label.

Moderate risk, FDA, Labeling error

Olympus BiCOAG Hemostasis Probe

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

Moderate risk, FDA, Device defect

Heidelberg Engineering SPECTRALIS with Flex Module

The Spectralis with Flex Module imaging platform can tip over when wheels come loose, causing impact or crushing injuries.

Moderate risk, FDA, Device defect

3 recalls

Pi-Cardia ShortCut Device

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

Moderate risk, FDA, Device defect

CADD Yellow Medication Cassette Reservoir with NRFit Connector

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing.

Moderate risk, FDA, Device defect

F & A Foundation Reign Medical Clench Staple System (Compression)

The Reign Medical Clench Staple System has not had its performance characteristics adequately established.

Moderate risk, FDA, Device defect

12 recalls

Halyard Medical Trays

Haylard 18G Single Shot EPI Tray may have quality and sterility issues.

High risk, FDA, Sterility problem

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

Medical Action Blood Culture Collection Kits

Medical Action Blood Culture Collection Kits contain applicators with an open or incomplete seal that may compromise sterility and lead to infection.

Moderate risk, FDA, Sterility problem

Howmedica Osteonics Orthopaedic Implant Components

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

Moderate risk, FDA, Device defect

restor3d Kinos Axiom Total Ankle System with Axiom PSR, Flat-Cut (Cut Guide)

The Kinos Axiom Total Ankle System was packaged with incorrect cutting guides, which may cause delayed surgery, poor alignment, or need for revision.

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

7 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

SunMed Tracheal Tube

The tracheal tube has a suction catheter that may not pass through smoothly.

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