Baxter Likorall Overhead Lifts
Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.
Device defect recalls
Recalls flagged for device defect, newest first. 384 recalls
2 recalls
BioFire FilmArray Pneumonia and Joint Infection Panels
BioFire Diagnostics is recalling 3 products.
3 products
1 recall
Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4)
The HemoslL AcuStar HIT-lgG(PF-4) may have an invalid calibration curve or negative mean bias with patient samples.
2 products
7 recalls
Integrated Medcraft FORWARD Gunshot Wound Kit
The Forward Gunshot Wound Kit has a sterile pad that may degrade over time, potentially causing pad remnants to dislodge near a wound.
Sarnova Curaplex Capnography Oral Nasal Cannula Multipack
The Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack contains pediatric nasal cannulas instead of adult ones.
Boston Scientific NaviFlex LW Pusher and Advx Panc Stent
The device was incorrectly manufactured with a guidewire exit port, which is not a design feature.
Neuronetics NeuroStar Advanced Therapy Systems
The NeuroStar Advanced Therapy System has cables that are not in conformance with product specifications.
Cadwell IOMAX Cortical Module
The IOMAX Cortical Module may unintentionally deliver electrical stimulation or allow unintended current to reach the patient.
Becton Dickinson BD Phoenix Panels NMIC-306 and NMIC-312
BD Phoenix Panel NMIC-312 may have quality control failures with Klebsiella pneumoniae.
2 products
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.
3 products
5 recalls
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.
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.
8 products
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.
Canon Medical Alphenix INFX-8000C/B5
The Alphenix INFX-8000C/B5 has bolts that may loosen, causing the tabletop to shift and misalignment.
Polymedco Sediplast
Sediplast tubes may resist insertion, causing cap ejection and blood exposure.
1 recall
Onkos Surgical My3D Personalized Pelvic Implant
My3D Personalized Pelvic Implants were inadvertently mixed up and distributed to incorrect customers.
2 recalls
Medtronic MiniMed Flex Insulin Pumps
The MiniMed Flex insulin pump may have failed verification tests, leading to issues such as inaccurate insulin delivery.
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.
2 products
3 recalls
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.
DRG International Sperm Ab ELISA
Potential for false negative patient results.
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.
6 products
4 recalls
Medline Homecare Beds and Hand Pendants
Hand pendants for Medline homecare beds can overheat, posing a fire hazard.
2 products
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.
Atellica CH Revised C-Reactive Protein (RCRP)
The potential for falsely elevated results.
Wright Medical Technology Charlotte Claw Screw
The screw has missing threads on the screwheads, which may prevent secure engagement with the plate.
3 recalls
Philips Spectral CT 7500
The Spectral CT 7500 software may crash during bolus tracking.
Olympus Tripp-Lite DisplayPort Cables
The DisplayPort cable may cause a video dropout or blackout in high-power mode.
Quantum PureFlow Standard Heat Exchanger
The Quantum PureFlow Standard Heat Exchanger can leak blood-to-glycol.
2 products
5 recalls
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.
4 products
Heraeus PALACOS Bone Cement Mixing and Application Systems
Palacos R pro bone cement has a potential for monomer liquid leakage.
4 products
EnCor EnCompass Breast Biopsy and Tissue Removal System Console
The breast biopsy system may experience errors that interrupt or prolong the procedure.
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.
4 products
HeartSine Samaritan PAD Public Access Defibrillators
HeartSine samaritan PAD defibrillators were distributed without the required Maintenance Supplement.
3 recalls
New York Embroidery Studio Trinity Non-Surgical Isolation Gown
The isolation gowns may not meet liquid-barrier performance requirements.
Cardioroot Woven Collagen Coated Vascular Graft
The Cardioroot Woven Collagen Coated Vascular Graft failed water permeability acceptance criteria.
Imager II Angiographic Catheters
Imager II Angiographic Catheters may fracture or detach, leading to device fragments remaining or migrating.
2 recalls
DeRoyal Myocardial Probe 400 Series
Myocardial temperature probes contain an incorrect needle, an 18mm needle instead of a 15mm needle.
NGenuity Patient Monitor with Capnography (ETCO2)
The patient monitor can show a Checkline Error alarm at setup, which may delay the procedure.
10 recalls
Pearle Vision 1 day (Somofilcon A) Contact Lens
Some Pearle Vision 1 day contact lenses have the incorrect power.
bioMérieux VITEK 2 AST-N461 Test Kit
The Vitek 2 AST-N461 test kit may cause false resistant results due to card pouch damage.
Medline Convenience Kits Containing Healthmark Instrument Channel Brushes
Medline convenience kits contain brushes with a sharp edge that can cut and infect.
2 products
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.
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.
SeaSpine Mariner Deformity Extended Polyaxial Head
The spinal device has a thread depth out of design specification.
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.
2 products
Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
4 products
Olympus BiCOAG Hemostasis Probe
The Olympus BiCOAG Hemostasis Probe may have a ceramic tip that can detach.
4 products
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.
3 recalls
Pi-Cardia ShortCut Device
The ShortCut transfemoral catheter has a detaching positioning arm due to a weld issue.
CADD Yellow Medication Cassette Reservoir with NRFit Connector
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing.
