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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 is recalling 24 units of the Intera Achieva 1.5T Pulsar MRI System because the patient support table floor plate may be incorrectly installed. Worldwide distribution affected.
Philips is recalling 9 Intera 3.0T Quasar Dual MRI systems (Model 781150) distributed worldwide. The patient support table floor plate may be incorrectly installed on these units.
Philips is recalling 14 Intera 0.5T MRI systems due to potential misinstallation of the patient support table floor plate, which could affect equipment stability and patient safety.
Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.
Philips is recalling 1,921 Achieva 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed. Healthcare facilities should verify proper installation.
Philips is recalling one Achieva 3.0T for PET MRI system with a patient support table floor plate that may be incorrectly installed.
Philips is recalling 135 Ingenia 1.5T S MRI systems worldwide because the patient support table floor plate may be incorrectly installed, creating a potential safety risk to patients and staff.
Baxter Healthcare is recalling marketing brochures for surgical vessel occluders and related devices because the brochures contain information that does not match the official product instructions for use.
Philips North America is recalling 131 Ingenia Elition S magnetic resonance imaging systems due to incorrect installation of the patient support table floor plates.
Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.
Actim PROM dipstik fetal membrane rupture test kits are recalled because personal lubricants can interfere with the test, producing false positive results.
Philips is recalling 46 units of the Intera 1.5T Achieva Nova MRI system due to improper installation of the patient support table floor plate. The defect may compromise patient safety during use.
Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.
Philips is recalling the Achieva 3.0TX PET-MRI system because the patient support table floor plate may be incorrectly installed.
Smiths Medical syringe pumps with defective barrel clamp guides may fail to recognize or correctly identify loaded syringes, potentially affecting medication delivery accuracy.
Philips North America is recalling GYROSCAN T10-NT MRI systems due to potential incorrect installation of the patient support table floor plate. Affected units should be verified for proper installation.
Philips is recalling 347 Intera 1.5T MRI systems worldwide because the patient support table floor plate may be incorrectly installed, potentially compromising patient support stability during use.
Philips is recalling 69 units of the Achieva 1.5T Initial MRI system due to potential issues with the patient support table floor plate installation, which may affect patient safety during imaging.
Unomedical A/S is recalling 10,770 units of Neria Soft Infusion Sets because certain lots were shipped with incorrect instructions for use. The wrong instruction manual for Rest of World markets was included instead of the FDA-approved US version.
Philips Evolution 3.0T MRI systems may have an incorrectly installed patient support table floor plate, creating a potential safety risk. Affected facilities should verify proper installation.
Philips Ingenia Ambition X MRI systems may have incorrectly installed patient support table floor plates. This affects 404 units distributed worldwide.
Philips has recalled 511 units of the Achieva 3.0T Magnetic Resonance System due to a potential installation defect in the patient support table floor plate, which could affect table stability and patient safety.
Baxter Healthcare is recalling surgical and cardiovascular device marketing brochures that contain information conflicting with the official Instructions for Use. The inaccurate content could lead to incorrect device use.
Philips Intera 1.0T MRI systems may have patient support table floor plates that are incorrectly installed. The defect poses a potential safety risk to patients. Facilities should verify installation and contact Philips service personnel for inspection.
Siemens Artis interventional X-ray systems may fail to cool the X-ray tube adequately, causing system shutdown and potentially requiring cancellation of clinical imaging procedures. The recall affects 583 units distributed nationwide.
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