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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 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.
Philips is recalling 344 Ingenia Ambition S MRI systems because the patient support table floor plate may be incorrectly installed.
Cook Incorporated is recalling Chiba Biopsy Needles due to packaging that may have low seal strength, potentially compromising device sterility. The recall affects 6,178 units distributed worldwide.
Philips is recalling 49 Achieva XR magnetic resonance imaging systems worldwide due to an incorrectly installed patient support table floor plate that may affect equipment stability and patient safety.
Philips recalls 25 Intera 1.5T R11 MRI systems due to potential incorrect installation of the patient support table floor plate, which may affect patient safety during device operation.
Philips is recalling 672 units of its SmartPath to dStream MRI system because the patient support table floor plate may be incorrectly installed, posing a patient safety risk.
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.
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 Ingenia 3.0T MRI systems due to incorrect patient support table floor plate installation. Affected healthcare facilities should verify installation status and contact Philips for corrective action.
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.
Smiths Medical is recalling certain Medfusion Models 4000, 3500, and 3010 syringe pumps due to a barrel clamp guide defect. The defect may prevent the pump from recognizing or correctly identifying a syringe, potentially affecting medication delivery.
Philips is recalling 115 Achieva 1.5T MRI systems due to potential incorrect installation of the patient support table floor plate.
Philips Intera CV MRI systems may have an incorrectly installed patient support table floor plate. Eight units have been recalled due to this installation defect.
Randox Laboratories is recalling its Microalbumin Calibrator Series due to a negative bias in its calibration. This could misclassify patient results and affect Quality Control procedures by up to 12%.
Philips MRI systems may have an incorrectly installed patient support table floor plate, creating a potential stability risk during patient imaging.
Philips is recalling 166 units of the MR 5300 Magnetic Resonance System worldwide because the patient support table floor plate may be incorrectly installed on affected units.
Ethicon recalls 395 units of STRATAFIX surgical sutures (lot SHBAEC) due to sterility compromise from environmental exposure during transit and storage. Product is unsuitable for surgical use.
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.
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.
Masimo Corporation is recalling 443 Rad-G pulse oximeters that may automatically power off and on, interrupting patient monitoring. Affected units are distributed worldwide.
Smiths Medical is recalling certain Model 3010 syringe pumps due to a molding defect in the barrel clamp guide that may prevent proper syringe recognition. Affected units were manufactured or serviced between July 2016 and April 2021.
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 Intera 1.0T MRI systems may have an incorrectly installed patient support table floor plate. This defect could affect patient safety during magnetic resonance imaging procedures.
Philips is recalling 33 Enterprise 1.5T MRI systems due to patient support table floor plates that may be incorrectly installed.
Artivion is recalling one CryoValve SG cryopreserved heart valve contaminated with Staphylococcus aureus, detected during organ donation screening. No illnesses have been reported.
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