Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Medtronic is recalling 7,469 dual chamber pacemakers worldwide due to a circuit error that may affect device functionality when programmed to specific modes.
Medtronic is recalling specific Sphera DR MRI SureScan pacemakers worldwide due to a circuit error that may affect device functionality when programmed to dual chamber mode.
Medtronic is recalling specific Adapta, Versa, and Sensia dual chamber pacemakers due to a circuit error that may affect device functionality.
Medtronic is recalling specific dual chamber pacemakers distributed worldwide between 2017 and 2019 due to a potential circuit error affecting device functionality.
Steris Corporation is recalling 129 ATLAS Loading Cars because the latch may fail to engage when empty, causing the unit to slide or fall.
AtriCure is recalling 1,288 COBRA FUSION 50 Ablation Systems because patients may face an elevated risk of thromboembolism during specific off-pump procedures.
Philips is recalling 146 CombiDiagnost R90 X-ray systems because a software defect may cause patients to receive increased radiation doses.
AtriCure is recalling 175 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.
Edwards Lifesciences is recalling the Edwards Commander Delivery System due to reports of crimp and inflation balloon component separation during TAVR procedures.
OMNIlife science Inc. is recalling seven OMNI K1 Broach Handles because the inner pin may become loose and fall out.
Cincinnati Sub-Zero is recalling 396 Hemotherm CE Dual Reservoir Cooler/Heater units because fuse clips may stretch, causing overheating and device shutdown.
Signature Orthopedics is voluntarily recalling three Genius Knee Cemented CR Femoral Components due to a product mix-up. The devices were distributed in Florida, New York, and Tennessee.
The Magstim Company Limited is recalling 27 HORIZON Ez Arm units because a stray stainless-steel cable strand may protrude from the heat shrink sleeving on the Balance Cable.
Philips is issuing a software update for 24 Ingenuity TF PET/CT systems to correct multiple issues identified in the previous software version.
Ottobock is recalling 538 PushValve units because some valve inserts have a diameter smaller than the specification. The valve is used for prosthetic fitting of lower limb amputees.
Signature Orthopedics is recalling 10 Genius Knee Cemented Tibial Components due to a product mix-up. The recall covers units distributed in Florida, New York, and Tennessee.
Ottobock is recalling 110 MagValve units used in prosthetic sockets because some valve inserts have a smaller diameter than specified.
Ottobock is recalling PushValve upper parts because some installed valve inserts have a diameter smaller than the specification.
Luminex Corporation is recalling Verigene BC-GP Utility Kits because they were incorrectly labeled with Amplification Tray labels.
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Smiths Medical is recalling Portex 350 ml Sterile Water Humidifiers because leaking containers may expose patients to infectious agents.
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Medex Cardio-Pulmonary Inc. is recalling 54,924 Medline Prefilled 550 ml Sterile bags due to leaking containers that may compromise sterility.
Terrific Care LLC is recalling CoaguChek XS PT Test Strips sold via MedEx Supply due to potential for abnormally high INR test results.
Smiths Medical is recalling Portex 1000 ml Sterile Water USP Pour Bottles because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.
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