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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 448 Ingenia Elition X MRI systems worldwide due to potentially incorrect installation of the patient support table floor plate, which could compromise structural integrity.
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.
Smiths Medical is recalling Medfusion Guide Barrel Clamps due to a molding defect that could cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.
Cook Incorporated is recalling 1,493 Dilators With AQ Hydrophilic Coating due to packaging that may not maintain proper seal strength, potentially compromising device sterility.
Philips has recalled 50 units of its GYROSCAN ACS-NT MRI systems. The patient support table floor plate may be incorrectly installed, potentially posing a safety risk.
Philips North America is recalling 131 Ingenia Elition S magnetic resonance imaging systems due to incorrect installation of the patient support table floor plates.
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.
Smith & Nephew is recalling RENASYS EDGE 800ML canisters due to black particulate matter from the carbon filter potentially damaging the NPWT pump. Affected patients should contact their healthcare provider.
Conformis is recalling Identity Imprint PS Tibial Tray Size 4 implants due to a packaging error where Size 5 components were placed in Size 4 boxes with incorrect lot numbers.
Philips has recalled Intera 1.5T Achieva Nova-Dual MRI systems due to incorrect installation of the patient support table floor plate. The recall affects 20 units distributed worldwide.
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.
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.
Siemens Atellica CH and CI analyzers may produce falsely elevated cholesterol and lipid test results (2–16% high) after iron tests. This affects clinical calibration, quality control checks, and patient test results.
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.
Cook Incorporated recalled the Yueh Centesis Disposable Catheter Needle due to packaging with low seal strength that may compromise device sterility. The recall affects 296 units distributed worldwide.
Actim PROM dipstik fetal membrane rupture test kits are recalled because personal lubricants can interfere with the test, producing false positive results.
Philips has recalled 2 Intera 1.5T MRI systems due to potential incorrect installation of the patient support table floor plate.
Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.
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 115 Achieva 1.5T MRI systems due to potential incorrect installation of the patient support table floor plate.
Philips Ingenia Ambition X MRI systems may have incorrectly installed patient support table floor plates. This affects 404 units distributed worldwide.
Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.
Cook Incorporated recalled 55 Trocar Needles (Lot 15786588) due to packaging that may not meet peel strength specifications, potentially compromising device sterility. Units were distributed nationwide and internationally.
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 North America is recalling 7 GYROSCAN T5 MRI systems worldwide due to potential incorrect installation of the patient support table floor plate, which may create a safety risk during patient table use.
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