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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 Healthcare is recalling CombiDiagnost R90 X-ray systems because some units lack required FDA radiation warning labels and X-ray certification statements. No injuries have been reported.
Monitor bracket assemblies in Philips Continuous CT Fluoroscopy systems may experience significant wear and detach, potentially injuring patients, operators, or bystanders during surgical procedures.
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.
Medtronic recalls 2 Endurant Stent Graft System devices due to potential spindle detachment from the hypotube during surgical deployment. The mechanical failure could affect graft positioning.
Western/Scott Fetzer Company is recalling 40 units of the Oxytote DTE Digital VIPR System due to battery rupture risk. The device may emit fumes and smoke when the battery ruptures and plastic shroud breaks apart.
Medtronic wireless rechargers for the Activa RC neurostimulator may become unresponsive if charging instructions from the patient user guide are not precisely followed. Approximately 6,406 devices are affected nationwide.
Philips Healthcare is recalling Azurion systems with software releases 2.1(L1) and 2.1(L2) due to a software defect that prevents proper reconstruction of 3D X-ray images when the detector is positioned outside required tolerance.
Abbott ARCHITECT clinical chemistry analyzers with software 9.41 and earlier contain defects affecting calibration, sample handling, and quality control that may produce inaccurate diagnostic results.
The Binding Site Group recalled 2,254 Freelite Human Lambda Free Kits due to calibration curve issues that may produce higher-than-expected activity readings and affect measurement accuracy.
Siemens Artis Q angiography systems may fail to release x-ray when source-to-image distance lift and x-ray release are activated simultaneously, causing procedure delays.
A software issue in SOMATOM Definition AS CT scanners may cause workflow interruptions, leading to diagnostic delays and the need for patient rescans. The recall affects approximately 665 units distributed nationwide.
Siemens has recalled two Artis Q.zen angiography systems due to a software issue that may prevent x-ray imaging and delay procedures when SID lift and x-ray controls are activated simultaneously.
Siemens Artis zee biplane X-ray imaging systems may fail to release X-rays when the source-to-image distance lift is activated simultaneously, resulting in procedural delays.
Siemens is recalling 19 units of its Artis zee angiography system due to a software issue that may prevent x-ray activation under specific operating conditions, causing procedural delay.
Three Siemens Artis Q.zen angiography systems may fail to fire X-rays when the source-to-image distance lift is activated simultaneously with X-ray commands. This causes a procedural delay.
Intuitive Surgical recalls 1,740 da Vinci Instrument Arm Drapes due to incorrect expiration dates on package labeling. The error may prevent accurate verification of sterility assurance dates.
Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.
Siemens Artis Q floor angiography systems may fail to produce x-ray when SID lift movement is activated during x-ray release, resulting in procedural delays. The system displays an error message.
Siemens Medical Solutions is recalling 15 Artis Q biplane diagnostic x-ray systems due to a software issue in the VD12-angiography subsystem. When source-to-image distance lift is activated simultaneously with x-ray release, the system fails to activate and displays an error message, causing procedural delay.
Siemens is recalling 15 Artis Q.zen angiography systems that may fail to generate x-rays when the lift mechanism and x-ray release are activated simultaneously, potentially causing a procedural delay.
Philips Healthcare is recalling ProxiDiagnost N90 diagnostic X-ray systems that lack required FDA radiation warning labels. Some units nationwide were found missing the mandatory radiation safety labels and certification statements required by federal standards.
Siemens Artis zee floor angiography systems may fail to release x-rays when the SID lift and x-ray functions are activated simultaneously, causing procedural delay. Three units are affected.
Arrow-Trerotola PTD catheters are being recalled because the inner lumen can detach from the device basket, causing embolization that requires additional intervention. 1,167 units are affected.
Scrip Inc is recalling Scrip Ultrasound Gel Clear (5L) nationwide due to potential bacterial contamination. Affected units may cause harm if contaminated product contacts patients during ultrasound procedures.
Arrow International is recalling Arrow-Trerotola Percutaneous Thrombolytic Device catheters because the inner lumen can detach from the device basket, causing embolization requiring additional intervention and delaying dialysis therapy. Approximately 1,245 units are affected worldwide.
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