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.
Baxter Healthcare is recalling power cords for the AMIA Automated PD Cycler because the socket may detach when unplugged.
Siemens Medical Solutions is recalling SOMATOM Scope devices due to a software issue that may cause unnecessary radiation exposure.
GE Healthcare is recalling 42 Revolution EVO 3.6 CT systems installed with a specific electrical panel that may not be properly wired to the UPS.
Galt Medical Corporation is recalling specific lots of Drainer and Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins.
GE Healthcare is recalling 42 Discovery MI CT systems installed with a specific electrical panel that may not be properly wired to the UPS.
Siemens Medical Solutions USA is recalling SOMATOM Perspective 16 CT scanners due to a software issue that may cause unnecessary radiation exposure.
Stryker Neurovascular is recalling FlowGate2 Balloon Guide Catheters because the balloon diameter may exceed specifications, potentially causing resistance during use.
GE Healthcare is recalling 42 Discovery RT CT systems nationwide due to a potential wiring defect in the electrical panel that may affect the uninterruptible power supply.
bioMerieux, Inc. is recalling VIDAS LH test kits because internal tests confirmed a decrease in strip signal over time, leading to invalid calibration results.
ELITech Clinical Systems is recalling ENVOY 500 ISE Calibrator Kits because some vials cause calibration errors, delaying patient results.
Howmedica is recalling five custom implant systems because they lacked updated instructions clarifying the locking mechanism and screw warnings.
Natus Neurology is recalling 171 Nicolet Ambulatory EEG devices because they may allow users to import exams that were not started.
Randox Laboratories is recalling Liquid Cardiac Control - Level 3 due to unacceptable variation between vials that may delay Troponin T test results.
LivaNova is recalling 243 VNS Therapy Programming Systems because they may display unintended warning messages. The devices were distributed to 16 U.S. states.
Envoy Medical is recalling four Esteem II Sound Processors because the sterile wipes inside expired before the date labeled on the final pack.
Encore Medical is recalling 30 instrument trays used for AltiVate Small Shell Trials because a black coating may appear after cleaning that is not biocompatible.
Diamedix Corporation is recalling 505 units of the Is-Mumps IgG Enzyme Immunoassay Test Kit because a gel-like contaminant may affect product performance.
Diamedix Corporation is recalling 147 units of the Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit due to a gel-like contaminant that may affect product performance.
Becton, Dickinson and Company is recalling 8 BD FACS Universal Loader devices because the solenoid plunger tip is too short to lock securely during use.
Olympus is recalling 2,399 Uretero-reno fiberscopes because the insertion tube bending section may break during surgery.
Cayenne Medical Inc. is recalling specific models of the AperFix Femoral Implant Coring Removal Drill due to a trend of premature wear and breakage identified in 2010.
DePuy Orthopaedics is recalling two lots of CORAIL femoral stems labeled as Size 11 but actually Size 12 due to fit and mechanical risks.
Philips Healthcare is recalling 459 Allura Xper systems because shutter positions reset when procedure types change, potentially affecting imaging accuracy.
Siemens is recalling six AXIOM Artis angiography systems in the US due to a defective sealing that could allow coolant to leak into electrical parts.
Implantcast GmbH is recalling specific 2M insert 15degree orthopedic hip implant components because the retaining ring may be incorrectly mounted.
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