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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.
Medline Industries is recalling 162 units of Centurion CirClamp surgical devices due to incorrect subassembly size. The defect could affect proper device function during surgical use.
Medtronic is recalling INFINITY Multi-Axial Spinal Screws due to incorrect titanium material used in manufacturing, which reduces the gripping strength of the screw head. The affected screws are used for spinal fusion and stabilization.
Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device due to potential breakage of the small screw that affixes the anti-backout plate. The recall affects 34 units distributed in the United States.
Medtronic is recalling 10 units of INFINITY Multi-Axial Screws distributed in the US and Canada because incorrect titanium material reduces gripping strength in affected lots.
Beckman Coulter is recalling Access Free T3 reagent test kits (Catalog #A13422, Lot #233968) because approximately 15-20% of samples produce falsely elevated results that could lead to misdiagnosis and inappropriate thyroid treatment.
Medtronic is recalling 45 units of INFINITY Multi-Axial Screws (lot H5802983) worldwide because incorrect titanium was used, reducing the screw head's gripping strength. No illnesses or injuries have been reported.
Baxter Healthcare Corporation is recalling the ExactaMed 20 mL Oral Dispenser (Lot B301S356P) because it may contain particulate matter. The recall affects approximately 91,100 units distributed in the US.
Medtronic is recalling INFINITY spinal implant screws manufactured with incorrect titanium material. The defect reduces the screw's gripping strength, risking implant performance in critical spinal fusion surgery.
Medacta Usa Inc is recalling MectaLIF ANTERIOR antibackout lag covers due to potential breakage of the small screw that affixes the anti-backout plate. The defect affects spinal fusion procedures in select US states.
Medacta Usa Inc is recalling the MectaLIF ANTERIOR Lag Plate Flush H10 interbody fusion device due to a potential risk of screw breakage in the anti-backout plate. No injuries have been reported.
Radiometer is recalling AQURE laboratory software versions 2.5.2 through 2.6.1 due to a potential issue that could cause patient data mix-ups.
Philips recalls SmartPerfusion cardiac imaging software for technical issues in signal generation and processing that can produce inaccurate diagnostic output.
Medtronic is recalling 90 INFINITY Multi-Axial Screws (Lot H5806345) due to incorrect titanium material that reduces screw head gripping strength. The defect affects 5 batches distributed in the US and Canada.
BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel test kits due to a manufacturing issue that may produce false negative results. Affected units may fail to detect gastrointestinal infections.
Medacta Usa Inc is recalling the MectaLIF ANTERIOR interbody fusion device because the small screw affixing the anti-backout plate may break, potentially compromising device integrity.
Philips is recalling 2D Perfusion diagnostic imaging software due to signal processing errors that can produce inaccurate presentations, potentially affecting clinical decisions.
GEO Instrument Kits for EPS Plates contain drill guides marked with an incorrect depth range (30mm-60mm instead of 10mm-40mm), which could affect surgical implant placement.
The FDA is recalling the Tobii Dynavox TD I-110, a speech-generating device, because the battery may become loose from its housing and potentially be damaged. This affects users worldwide who depend on this device for communication.
Boston Scientific recalls the Habib EndoHPB Bipolar RF Catheter used in pancreatic and biliary procedures due to inaccurate instructions that could result in excessive energy delivery and thermal injury.
Compass Health Brands is recalling the REX Pressure Therapy System because the user manual incorrectly claims the device can prevent deep vein thrombosis, an indication for which the device was not FDA-cleared.
Pro-Dex Inc is recalling 199 KLS E-Coupling Adapter devices due to incorrect Unique Device Identifier (UDI) and GTIN codes. The devices were distributed nationwide.
Medtronic recalled approximately 1414 SenSight Extension Tunneler Kits due to a manufacturing defect where dual carriers were machined on only one side, preventing use for passing two extensions simultaneously.
Ortho-Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total N Antibody Calibrators used in COVID-19 testing due to incorrect calibrator levels in Assay Data Disks, which can delay patient test results.
Avanos Medical is recalling Ballard Oral Care Swabs (codes 12241, 12243, 12251) due to incorrect expiration date labeling. The recall affects 5,475 cases distributed worldwide.
Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because fluid ingress can damage the device, causing loss of electrical function and preventing or halting infusion.
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