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FDA medical device recalls

Medical device recalls from FDA, newest first. 876 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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10 recalls that day

Beckman Coulter DxC 500 Clinical Chemistry Analyzers

Beckman Coulter DxC 500 Clinical Chemistry Analyzers have a software issue that can cause falsely elevated results.

Moderate risk, FDA, Software defect

DRG International Sperm Ab ELISA

Sperm Ab ELISA may give false negative patient results.

Moderate risk, FDA, Device defect

Spectral CT and Spectral CT 7500 RT

Spectral CT systems 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 indicators and test packs may show no growth even if the steam cycle did not achieve the intended spore reduction.

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 an inadequate weld in the head positioning system.

Moderate risk, FDA, Manufacturing problem

9 recalls that day

Medline Homecare Beds and Hand Pendants

Hand pendants for homecare beds may overheat, causing smoke, sparks, melting, burning, or fire.

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)

Atellica CH Revised C-Reactive Protein (RCRP) may give 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 but the validated shelf life is 5 years.

Moderate risk, FDA, Labeling error

Wright Medical Technology Charlotte Claw Screw

The Charlotte Claw Screw has missing threads on the screwheads, which may prevent secure engagement and lead to surgery prolongation or alternative methods.

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 that day

Philips Spectral CT 7500

The Spectral CT 7500 may crash during a scan, causing additional radiation.

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 version 2.13 has a software issue preventing pairing with certain 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 that day

Pipeline Flex Embolization Device with Shield Technology

The Pipeline Flex Embolization Device with Shield Technology has incorrect label/product dimensions, with a unit packaged as 2.50 mm instead of 3.00 mm.

Moderate risk, FDA, Labeling error

Percussionaire Intrapulmonary Percussive Ventilation and Phasitron Breathing Circuits

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

Moderate risk, FDA, Labeling error

13 recalls that day

Philips MRI Scanners and Upgrade Kits

When exporting diffusion tensor imaging scans from an MR system using the Enhanced MR Dicom format, the exports contain incorrect data.

Moderate risk, FDA, Software defect

NOxBOXi Nitric Oxide Delivery System

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

Moderate risk, FDA, Manufacturing problem

Olympus M3 Gold Autoclavable Foroblique Telescope 30 and Lateral Telescope 70

The sterilization parameters listed in the Instructions for Use differ from those in the Japanese package insert.

Moderate risk, FDA, Sterility problem

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

Presource packs containing Stryker StrykeFlow PS and AHTO tube sets may leak during use, causing fluid to pool on the floor and potential slips.

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, or 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.

Moderate risk, FDA, Software defect

Volcano Philips IntraSight Plus

Philips IntraSight Plus may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

Moderate risk, FDA, Software defect

Heraeus PALACOS Bone Cement Mixing and Application Systems

Palacos bone cement has a potential for monomer liquid leakage.

Moderate risk, FDA, Device defect

EnCor EnCompass Breast Biopsy and Tissue Removal System Console

The EnCor EnCompass 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 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, which describes an extra check every 3 months.

Low risk, FDA, Device defect

2 recalls that day

Medline Convenience Kits

Medline Convenience Kits contain neurological sponges with potential for unexpected variability of endotoxin levels.

Moderate risk, FDA, Contamination

Baxter Pro+ MRS Surfaces for VersaCare

The Pro+ MRS Surface for VersaCare mattress has an error in its UDI label description, which may lead to incorrect product identification or selection.

Moderate risk, FDA, Labeling error

6 recalls that day

Halyard IV Start Kits

The Halyard IV Start Kit may contain an applicator with an open or incomplete seal.

Moderate risk, FDA, Packaging defect, FDA event number 99764

Halyard IV Start Kits

The Halyard IV Start Kit may be contaminated with Aspergillus penicillioides.

High risk, FDA, Contamination, FDA event number 99761

New York Embroidery Studio Trinity Non-Surgical Isolation Gown

The isolation gowns do not consistently meet the minimum liquid-barrier performance required.

Moderate risk, FDA, Device defect

Cardioroot Woven Collagen Coated Vascular Graft

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

Moderate risk, FDA, Device defect

Imager II Angiographic Catheters

The tip of Imager II Angiographic Catheters may fracture or detach.

High risk, FDA, Device defect

Baxter Volara System

The Volara System may have a contaminated flow path affecting nebulizer flow rate accuracy.

Moderate risk, FDA, Contamination

3 recalls that day

DeRoyal Myocardial Probe 400 Series

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

Moderate risk, FDA, Device defect

Cardinal Health 200 Presource Convenience Kits

Presource Convenience Kits contain applicators that may have an open or incomplete seal, which could lead to infection.

Moderate risk, FDA, Contamination

NGenuity Patient Monitor with Capnography (ETCO2)

The nGenuity Patient Monitor with Capnography may show a Checkline Error alarm at setup.

Moderate risk, FDA, Device defect

2 recalls that day

ForeSight Elite Tissue Oximetry Cable

The ForeSight Elite Tissue Oximetry Cable has incorrect switching of Channel 1 and 2 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 or false alarms.

Moderate risk, FDA, Software defect

14 recalls that day

Philips Achieva, Ingenia, Intera and MR MRI Systems

A software issue in Philips MR systems will terminate an examination if reconstruction requirements exceed available system memory.

Moderate risk, FDA, Software defect

Pearle Vision 1 day (Somofilcon A) Contact Lens

Pearle Vision 1 day contact lenses have incorrect power in a small number of lenses.

Moderate risk, FDA, Device defect