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 MiniMed is recalling Paradigm Veo insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medline Industries is recalling 3,690 units of sterile 3mL syringes because voids in the packaging seal caused a loss of sterility.
Medtronic MiniMed is recalling 64,174 MiniMed Insulin Pumps (model MMT-508) due to potential cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 74,496 MiniMed Paradigm Insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
RaySearch Laboratories is recalling RayStation software because virtual wedge fields may not cover the entire field, resulting in a high dose plateau.
Medtronic MiniMed is recalling 17 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Carroll-Baccari, Inc. is recalling Wave Prep Tubes and single-use cups found to be contaminated with Burkholderia cepacia during an FDA inspection.
Insulet is recalling Omnipod DASH Personal Diabetes Manager devices because they may suggest inaccurate bolus amounts, potentially leading to hypoglycemia or hyperglycemia.
Bard Peripheral Vascular Inc is recalling 824 PowerPort isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.
Medtronic MiniMed is recalling 30,479 Paradigm Model 511 insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Medtronic MiniMed is recalling 2,322 Paradigm Veo insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Dexcom Inc is recalling G6 Continuous Glucose Monitoring Systems because the anti-neoplastic drug hydroxyurea may cause falsely elevated glucose readings.
Medtronic MiniMed is recalling 27 Paradigm insulin pumps due to a cybersecurity vulnerability that could allow unauthorized wireless control of insulin delivery.
Abbott is recalling Precision Xtra Blood Glucose & Ketone Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA and could lead to infection.
Dexcom Inc is recalling G5 and G4 PLATINUM Continuous Glucose Monitoring Systems because hydroxyurea use may cause falsely elevated glucose readings.
Medtronic MiniMed is recalling 10 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Karl Storz is recalling 21 RHINO-LARYNGO-BRONCHO FIBERSCOPE units because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.
Mavidon is recalling PediaPrep Tubes and Single use cups because samples were found contaminated with Burkholderia cepacia during an FDA inspection.
LivaNova is recalling 2,683 VNS Therapy Programmer Model 3000 units because a specific sequence of actions may trigger a false positive warning, potentially leading to unnecessary medical intervention.
Abbott is recalling Optium EZ Blood Glucose Monitoring Systems because instructions for disinfecting the devices were not cleared by the FDA, posing a risk of infection.
Intellijoint Surgical is recalling its Navigation System software because it may incorrectly calculate femur resection depth during total knee arthroplasty.
Medtronic MiniMed is recalling 73,028 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.
Carroll-Baccari, Inc. is recalling Mavidon CardioPrep Single products because samples were found contaminated with Burkholderia cepacia.
Karl Storz Endoscopy is recalling 73 flexible pediatric neuroscopes because the instruction manual contains incorrect sterilization information for the STERIS System 1E, which may compromise sterility.
Medline Industries is recalling 117,874 units of Winged Sponges Presaturated W/PVP because voids in the packaging seal caused a loss of sterility.
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