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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.
Philips Medical Systems is recalling 559 Brilliance iCT CT systems due to software issues affecting scan functions and safety features.
Medtronic is recalling MyCareLink Smart Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring alerts.
Becton Dickinson is recalling BD MAX CT/GC/TV kits due to increased rates of unresolved and indeterminate results, which may require repeat testing.
Smith & Nephew is recalling two units of bone plates due to incorrect labeling of the plate type.
Smith & Nephew is recalling two units of bone plates and screws that were incorrectly labeled as one model but contained a different model.
Becton Dickinson is recalling the BD MAX UVE Specimen Collection Kit because it may cause unresolved or indeterminate test results, potentially requiring re-testing.
Becton Dickinson is recalling the BD MAX Vaginal Panel due to an increased rate of unresolved and indeterminate results, which may require repeat testing.
Intuitive Surgical is recalling 60 da Vinci Xi EndoWrist Stapler 45 instruments due to a manufacturing variation that may prevent the release wrench from unclamping the device.
Smith & Nephew is recalling nine Radial Osteotome Blades because the expiration dates on the labels are incorrect. The devices were distributed in the US and Australia.
Measurement Specialties Inc. is recalling 6,076 reusable temperature probes because their sterilization instructions have not been proven through a validation study.
Smith & Nephew is recalling 12 units of EVOS 2.4MM Flex Plates because the packaging contained templates. The recall covers distribution to Oregon and Colombia.
The Anspach Effort, Inc. is voluntarily recalling one oscillating saw attachment because it was mistakenly shipped to a non-veterinary customer.
RaySearch Laboratories is recalling RayStation 6 software due to a defect in the proton QA module that may result in incorrect patient dosage calculations.
Merge Healthcare is recalling 1,150 power strips sold with the Merge Hemo System because an input resistor can overheat and cause the unit to smoke.
Zoll Manufacturing Corp. is recalling 33,670 LifeVest Wearable Defibrillators due to an incorrect service code that may prevent the device from detecting critical defects, potentially leading to defibrillation shock failure.
Boston Scientific is recalling ACCOLADE MRI SR Pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Roche Diagnostics is recalling 2,517 automated laboratory analyzers due to a software limitation that may cause sample mismatches.
Philips is recalling one Brilliance 64 CT scanner because certain fasteners may not be torqued to specification, posing a potential risk of harm if parts become loose.
Philips is recalling three Ingenuity Core 128 CT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.
Boston Scientific is recalling PROPONENT SR Pacemakers because reports indicate the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling certain pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ESSENTIO EL DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ACCOLADE MRI EL DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Hologic, Inc. is correcting 12 Affirm Lateral Arm Upright Biopsy Accessories in the U.S. due to a component issue that could impact needle alignment during lateral biopsy procedures.
Fujifilm is recalling Aspire Cristalle mammography machines because the swivel arm may move down unintentionally.
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