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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.
Isopure Corp is recalling 15 Acidified Concentrate Distribution and Storage Systems due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.
Polymer Technology Systems is recalling 44,448 refurbished CardioChek Plus Professional Analyzers because a battery terminal defect may cause overheating if batteries are inserted incorrectly.
Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Analyzers because a software issue may prevent specific gravity flags, potentially leading to erroneous test results.
GE Healthcare is recalling Centricity Universal Viewer 6.0 because incorrect measurements in DICOM files may lead to potential misdiagnosis.
Isopure Corp is recalling one IsoMix PRO system due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.
Palodex Group Oy is recalling 297 Soredex DIGORA Optime X-ray imagers because plastic insulation in the power supply may degrade, causing short circuits, heating, and smoke.
Palodex Group Oy is recalling Gendex GXPS-500 X-ray imagers because plastic insulation in the power supply may degrade, causing short circuits, heating, and smoke.
Paltop Advanced Dental Solutions is recalling 67 dental implants because some were packaged with the wrong cover screw, preventing proper fit.
Acclarent, Inc. is recalling three lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.
Medicrea International is recalling 190 units of Pass LP Blunt K-wires because they may not fit into Conical Cannulated Screws.
Arrow International is recalling 80 kits due to a lidstock label error that displays an MR Conditional symbol instead of MR Unsafe.
Acclarent, Inc. is recalling TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.
Acclarent, Inc. is recalling specific lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.
Siemens is recalling 3,627 ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.
Medicrea International is recalling 30 units of Pass LP Trocar K-wires because they may not fit into conical cannulated screws.
Siemens is recalling 12,796 ADVIA Centaur Folate 100 test kits because homocysteine assays may cause elevated folate results.
Greiner Bio-One is recalling 1,002,000 Vacuette tubes that may have cap sealing damage, potentially causing vacuum loss and improper blood volume collection.
Koios Medical is recalling 10 units of Koios DS Breast software due to insufficient documentation of required quality procedures.
Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate from its connector if used for more than six hours, potentially causing significant blood loss.
Trilliant Surgical is recalling 20 Gridlock Ankle Screw Driver Bits because they are out of specification and may fail to retain screws during implant procedures.
GE Healthcare is recalling 12 units of the Airway Gas Option N-CAiO because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling 161 CARESCAPE Respiratory Module E-sCAiO units because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling 37 CARESCAPE Respiratory Modules because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling three CARESCAPE Respiratory Module E-sCOVX units because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
GE Healthcare is recalling 59 CARESCAPE Respiratory Modules because displayed oxygen values may be incorrect, potentially causing up to 50% measurement error.
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