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.
Philips is recalling 116 CombiDiagnost GCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.
Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagent due to potential falsely depressed results for patients on phenindione therapy.
Siemens Medical Solutions is recalling 507 Ysio Max radiographic systems because a software bug may assign one image to two different patients, potentially affecting medical diagnosis.
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact sterility.
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Nobel Biocare is recalling 473 tapered dental drills because a packaging defect may compromise sterility during shelf life.
The FDA is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that could impact sterility.
Nobel Biocare is recalling 346 Guided Tapered Drills because a packaging sealing issue may compromise sterility during shelf life.
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise sterility.
Nobel Biocare is recalling Screw Tap Tapered WP Single-Pat devices because a packaging sealing defect may compromise sterility during shelf life.
Siemens is recalling 46 Luminos dRF Max devices because an override function can disable collision controls, creating a risk of collision with obstacles or persons.
Nobel Biocare is recalling 154 units of Tapered RP 4.3x13 mm drills because a packaging defect may compromise sterility.
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Nobel Biocare is recalling 31 units of Implant Retrieval Instrument CC 3.0 31 mm because a packaging sealing defect may compromise sterility.
Nobel Biocare is recalling 233 units of Abutment Screw Retrieval Instruments because a packaging defect may compromise sterility during shelf life.
Smith & Nephew is recalling TwinFix Ti 2.8 mm HS Suture Anchors because a protective tube failure may have breached the sterile barrier.
Siemens Medical Solutions is recalling 96 ARTIS Pheno-Interventional Fluoroscopic X-Ray Systems because safety brakes may block the robotic stand, preventing intended movements.
Nobel Biocare is recalling specific tapered dental drills because a packaging defect may compromise their sterility during shelf life.
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise the sterility barrier.
Nobel Biocare is recalling 260 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact the humidity or sterility barrier.
Nobel Biocare is recalling 87 units of Implant Retrieval Kits because a packaging sealing issue may compromise the sterility of the devices during their shelf-life.
Ormco/Sybronendo is recalling SnapLink brackets because the lower buccal tube slide doors may not stay closed, potentially causing tooth rotation and treatment delays.
Abbott Point Of Care Inc. is recalling i-STAT CG4+ cartridges because they are not FDA cleared and lack CLIA waived status.
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Looking for a different category? Browse all recalls.