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.
CareFusion is recalling SmartSite Extension Sets because they may disconnect or leak. The recall affects 21,000 units distributed in the US and Canada.
GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher because magnified projection X-ray images may display inaccurate distance measurements.
GE Healthcare is recalling Centricity PACS-IW software because it may display inaccurate distance measurements for magnified projection X-ray images.
Exactech is recalling eight Novation Element femoral hip implant stems that did not receive the specified Hydroxyapatite coating.
Philips is recalling 1,553 HeartStart MRx Monitor/Defibrillators because automated tests may degrade capacitors and the low battery indicator may fail.
Resource Optimization & Innovation LLC is recalling 255 Regard Custom Surgical Packs due to flow restriction issues in the trifurcated IV set.
Arrow International Inc is recalling 12,157 units of various PICC and midline catheter kits because the peel-away component hub tabs may prematurely detach during use.
Ivoclar A. G. is recalling specific lots of Helioseal F dental sealant because a production defect caused particles to be larger than defined, resulting in difficulties during extrusion.
Pyng Medical is recalling MATResponder and MATCombat tourniquets because some were not returned to the Ready position before packaging.
ELITech Clinical Systems is recalling specific reagents used on Selectra ProS and ProM systems due to potential drug interference. No complaints have been received.
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly where user-modified parameters revert to default values during ADD installation.
Biomet Spine is recalling 17 MaxAn cervical spine screws because 4.5 mm units were mislabeled as 4.0 mm.
ELITech Clinical Systems is recalling Eon 100 reagents due to potential drug interference. No complaints have been received.
Barco Inc. is recalling specific surgical display models because user settings are lost when the systems are powered off and back on.
Dako North America Inc. is recalling specific lots of EnVision FLEX visualization reagent kits due to a buffer defect causing non-specific background staining that interferes with result interpretation.
Stryker Spine is recalling 41 units of the UniVise Spinous Process Fixation Plate System Inserter because the inner shaft does not fit through the device.
ELITech Clinical Systems is recalling Eon 300 reagents due to potential drug interference. No complaints have been received.
ELITech Clinical Systems is recalling Envoy 500 reagent kits due to potential drug interference. No complaints have been received.
Philips is recalling 264 GEMINI PET/CT systems because the CT subsystem's Spindle Block Servo Controllers may fail prematurely.
Bausch + Lomb is recalling Biotrue ONEday contact lenses because a manufacturing defect on the lens surface may cause visual disturbances like halos or poor vision.
Steris Corporation is recalling 32 AMSCO 400 and AMSCO C Small Steam Sterilizers because a software defect prevents the foot pedal from operating the door.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 9, Lot 0954, due to an increase in wash error condition codes.
C.R. Bard is recalling 4,170 units of Antibacterial Hydro Personal Catheters because the unit label may incorrectly state the product code and size.
Siemens Medical Solutions is recalling 158 radiation therapy machines due to a potential safety risk of the gantry colliding with patients or treatment tables.
Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because compromised package integrity may affect sterility assurance.
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