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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.
Wright Medical Technology is recalling 40 units of Ortholoc 3DI locking screws because documentation confirming sterility was inadequate.
Wright Medical Technology is recalling 54 units of Valor Screws because adequate documentation confirming sterility was missing.
Boston Scientific is recalling Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 940 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Wright Medical Technology is recalling 66 units of sterile headed drill bits because documentation confirming sterility was inadequate.
Abbott is recalling Alinity ci Level Sensors, Bulk Solution, because environmental stress may cause cracks that affect reliability.
Wright Medical Technology is recalling 20 Swanson Trapezium Implants because the firm discovered a lack of adequate documentation confirming sterility.
Boston Scientific is recalling NC Emerge Monorail PTCA Dilatation Catheters because they may be missing a hydrophilic coating step during manufacturing.
Helena Laboratories is recalling Collagen Reagent kits because vials may contain particulate matter or microbial growth.
Boston Scientific is recalling 109 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Wright Medical Technology is recalling 30 Swanson Great Toe implants because the firm discovered a lack of adequate documentation confirming sterility.
Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 139 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Wright Medical Technology is recalling 65 units of INBONE STEM, TIBIAL, TOP components because adequate documentation confirming sterility was not found.
Howmedica Osteonics Corp. is recalling 40 units of Stryker X-Change Medial Wall Mesh Small (6-Petal) because boxes contain the 4-Petal version instead.
Wright Medical Technology is recalling 30 units of Evans Opening Wedge Plates because documentation confirming sterility was inadequate.
Boston Scientific is recalling 66 units of Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Boston Scientific is recalling 271 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
Abbott is recalling Alinity i accessory kits because environmental stress may cause cracks in the bulk solution level sensor.
Boston Scientific is recalling Advanix Pancreatic Stents labeled with a 36-month shelf life instead of the approved 18-month duration.
Boston Scientific is recalling Guidezilla II Guide Extension Catheters because they may lack a hydrophilic coating, potentially affecting device performance.
Wright Medical Technology is recalling 18 units of Swanson Finger Joint #2 implants because documentation confirming sterility was inadequate.
Bard Peripheral Vascular Inc is recalling 900 units of PowerPort isp M.R.I. Implantable Ports because they were packaged with the incorrect introducer sheath size.
Spineart SA is recalling 14 JULIET Ti OL cages due to a mismatch between the inner blister pack label and the external box label.
Spectranetics Corporation is recalling three AngioSculpt PTCA Scoring Balloon Catheters because the incorrect outer carton box was used for the product.
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