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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.
Helix Medical LLC is recalling 47 units of the Blom-Singer Adjustable Tracheostoma Valve II because the essential body component is missing from the packaging, rendering the device unusable.
St. Jude Medical is recalling 59 ablation catheters shipped with the wrong Instructions for Use (IFU). The recall covers specific batches distributed in six US states.
Intuitive Surgical is recalling da Vinci Vision System Cart components due to a coating incompatibility that triggers erroneous maintenance alerts.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Intact PTH Calibrators because some kits were packaged with only the high calibrator.
Pentax Medical is recalling 76 OF-B194 Gas/Water Feeding Valves due to a manufacturing defect that may cause improper CO2 gas stoppage during endoscopic procedures.
Synthes USA HQ, Inc. is recalling 319 units of the Sternal Zip Flex System because the application instrument may cut the implant, leading to loosening.
Atossa Genetics is recalling ForeCYTE Breast Health Test kits due to FDA concerns regarding instructions for use and promotional claims.
Edwards Lifesciences is recalling EMBOL-X Glide Protection Systems because the cannula tip may deform. The recall covers 12,034 units distributed in the US and Canada.
Medtronic is recalling Activa PC and RC deep brain stimulators due to a potential for overstimulation or stimulation in the wrong area during device recovery.
Siemens is recalling RAPIDLab and RAPIDPoint blood gas analyzers because users can enter wrong patient IDs, risking sample misidentification.
Globus Medical is recalling MicroFuse Putty because the sterility assurance level cannot be verified. The product is a bone graft extender used in medical procedures.
Toshiba is recalling 477 Xario XG Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.
GE Healthcare is recalling Centricity PACS-IW software due to issues that could display incorrect patient images or under-report dose values, posing a safety risk to patients.
Xoran Technologies is recalling Minicat CT Scanners that failed to meet specifications for dose rate, potentially affecting patient safety.
Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 400 series blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.
Xoran Technologies is recalling 320 MiniCAT CT Scanners because the gantry may fail to rotate while emitting radiation.
DePuy Spine is recalling 102 units of Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.
Siemens is recalling RAPIDPoint 405 blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.
Toshiba is recalling 427 Aplio MX Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.
Toshiba is recalling 17 diagnostic ultrasound systems because the transducer head may overheat under specific operating modes, posing a burn risk to patients.
bioMerieux, Inc. is recalling 90 units of chromID Salmonella Agar because Salmonella strains may grow as white colonies instead of the expected pink to mauve color, potentially leading to missed detections.
Medtronic is recalling RestoreUltra and RestoreSensor neurostimulators because they may deliver over-stimulation or stimulation to the wrong area under specific conditions.
Xoran Technologies is recalling 320 Mini CT Scanners because they failed to meet internal specifications for dose rate, with complaints indicating rates both high and low.
Siemens is recalling RAPIDLab 1200 Series blood gas analyzers because users may enter the wrong patient ID, leading to sample misidentification.
S.A.E. Afikim is recalling 69 Breeze C electric scooters because an electrical contact may fail, potentially preventing the driver from stopping the vehicle.
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