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Medical device recalls

Medical device recalls from FDA, newest first.
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1 recall

Medtronic OmniaSecure Model 3930M Leads

Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation.

Moderate risk, FDA, Device defect

4 recalls

Medline C-Section Drapes and Medical Convenience Kits

Medline C-Section Drapes and Medical Convenience Kits are difficult to remove from the patient and leave adhesive residue on the patient's skin.

Moderate risk, FDA, Device defect

Solstice Xact Mole Marker for Mammography

The Xact mole marker for mammography may have its radiopaque material detach, causing artifacts.

Moderate risk, FDA, Device defect

Medtronic InterStim SureScan MRI Leads and Percutaneous Extensions

Wrong lead or percutaneous extension selected.

Moderate risk, FDA, Device defect

Boston Scientific Direxion Torqueable Microcatheters

The Direxion Torqueable Microcatheter is defective due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

Moderate risk, FDA, Device defect

1 recall

Beckman Coulter Rotor SW40 and SW41

Beckman Coulter Rotor SW40 and SW41 may break into two or more pieces.

Moderate risk, FDA, Device defect

1 recall

Ventec Life Systems VOCSN, V+Pro, VC and V*Home Ventilators

The ventilator's internal flow transducer cable connector may disconnect from the internal board.

High risk, FDA, Device defect

5 recalls

Philips Smart-Hopping 2.0 AP 1.4 GHz

Philips Smart-hopping 2.0 AP 1.4 GHz has unreliable wireless roaming behavior that can cause loss of connectivity to the central monitoring system.

Moderate risk, FDA, Device defect

Medtronic NDI Passive Spheres and Biopsy Needle Kit

Medtronic NDI Passive Spheres and Biopsy Needle Kit have variation in reflective material that may affect navigation tracking.

Moderate risk, FDA, Device defect

Philips Lumify Diagnostic Ultrasound System

The Philips Lumify Diagnostic Ultrasound System may not recognize transducer registration, prevent scanning, or have unstable connections.

High risk, FDA, Device defect

Abbott Amplatzer Amulet Left Atrial Appendage Occluder

The Amplatzer Amulet Left Atrial Appendage Occluder has changes to its instructions regarding risk of pulmonary artery injury.

Moderate risk, FDA, Device defect

Axonics PNE Lead Implant Kit

The PNE Lead Implant Kit may leak, break, or experience other issues that may pose a risk to users.

Moderate risk, FDA, Device defect

5 recalls

Healthmark Vinyl Instrument Guards

Vinyl Instrument Guards have labeling that is not compliant with regulations and updated sterilization instructions.

Moderate risk, FDA, Labeling error

Intelerad IntelePACS and InteleConnect Portal Radiological Image Processing Systems

IntelePACS and InteleConnect Portal/Tech Portal may show report and displayed images that do not match.

Moderate risk, FDA, Device defect

Medline Surgical Convenience Kits

Medline surgical convenience kits contain cannula components that may leak or break during use.

Moderate risk, FDA, Device defect

Beckman Coulter DxU 840m Iris, DxU 850m Iris, IQ200 Sprint Analyzers

The DxU 840m Iris, DxU 850m Iris, IQ200 Sprint, IQ200 Select, and IQ200 Elite may leak lamina fluid, posing slip, chemical.

Moderate risk, FDA, Device defect

Radiometer Medical ABL90 FLEX and ABL90 FLEX PLUS Analyzers

The ABL90 Flex and ABL90 Flex Plus analyzers have a risk of potentially inaccurate results.

Moderate risk, FDA, Device defect

2 recalls

Steris Rapicide PA Part A High-Level Disinfectant

Rapicide PA Part A High-Level Disinfectant may swell if its vented cap is blocked, and could expose users to vapor or liquid.

Moderate risk, FDA, Device defect

Ethicon PERMA-HAND Silk Surgical Suture

PERMA-HAND Silk surgical sutures may contain alcohol-based fluid, causing surgical delay or tissue irritation.

Moderate risk, FDA, Device defect

2 recalls

Baxter Likorall Overhead Lifts

Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.

Moderate risk, FDA, Device defect

BioFire FilmArray Pneumonia and Joint Infection Panels

BioFire Diagnostics is recalling 3 products.

Moderate risk, FDA, Device defect

3 recalls

Ferno-Washington Power F2 Powered Fastening System

The Power F2 Powered Fastening System may have intermittent loss of powered function, causing reduced performance or delays in patient transport.

Moderate risk, FDA, Software defect

Neuronetics NeuroStar Advanced Therapy Systems

The NeuroStar Advanced Therapy System has cables that are not in conformance with product specifications.

Moderate risk, FDA, Device defect

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

3 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

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

Polymedco Sediplast

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

Moderate risk, FDA, Device defect

1 recall

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

1 recall

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

3 recalls

Glypto Device, Glypto Cryo Machine

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

Moderate risk, FDA, Unapproved product

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

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

3 recalls

Medline Homecare Beds and Hand Pendants

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

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

2 recalls

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

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

4 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

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

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

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

1 recall

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