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.
Boston Scientific is recalling ESSENTIO DR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling VISIONIST CRT-P pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ESSENTIO MRI SR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling PROPONENT EL DR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Consumers should check for discoloration on the protective seal.
Philips is recalling one Ingenuity Core CT scanner because certain fasteners cannot be confirmed to be torqued to specification, posing a potential risk of harm if parts become loose during use.
Boston Scientific is recalling ALTRUA 2 DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Hamilton Medical is recalling 176 Intellicuff Standalone devices because the motor may cease to function during use, potentially affecting endotracheal tube cuff pressure.
Boston Scientific is recalling ESSENTIO MRI EL DR Pacemakers because reports indicate the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ESSENTIO MRI DR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling ESSENTIO SR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Phadia US Inc is recalling 70 Phadia 1000 Instruments nationwide because a malfunctioning Retry command may cause solution shortages and affect test results.
Boston Scientific is recalling ACCOLADE DR pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Medtronic is recalling KYPHON Express Directional Bone Filler Devices because the directional arrow may not align with the opening.
Boston Scientific is recalling ACCOLADE EL DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling ACCOLADE MRI DR Pacemakers because reports indicate the Minute Ventilation sensor may intermittently over-sense signals.
Boston Scientific is recalling PROPONENT DR Pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Philips is recalling 13 Brilliance iCT 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 ACCOLADE SR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling VALITUDE CRT-P pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling PROPONENT MRI Pacemakers because of reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Boston Scientific is recalling VALITUDE X4 CRT-P pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
Fujifilm is recalling Aspire HD Plus and HD-s mammography machines because the swivel arm may drop unintentionally.
Boston Scientific is recalling ALTRUA 2 SR pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Users should check for discoloration or yellowing of the protective seal.
Looking for a different category? Browse all recalls.