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.
Zimmer Manufacturing B.V. is recalling specific lots of sterile hip and trauma implant screws because a small hole may be present in the inner tray.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglyceride reagent lots 348297 and 359932 because they fail linearity claims near end of shelf life.
Diamedix Corporation is recalling 150 Is-CMV IgG Test Kits because the product contained an incorrect substrate.
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Bradshaw Medical Inc. is recalling 3,760 Axial Torque Limiting Drivers because a component failure could cause applied torque to exceed the calibrated setting.
Biomerieux is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
St. Jude Medical is recalling 127 Ellipse ICD devices because they may fail to deliver high-voltage therapy needed to treat life-threatening heart rhythms.
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Stryker is recalling CinchLock SS Knotless Anchors after reports of internal wire breakage upon deployment.
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Medtronic is recalling 223 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, potentially leading to unsafe feeding conditions.
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Atlas Spine, Inc. is recalling 16 Torque Limiting Handles because they were not appropriately set to mitigate the risk of implant fracture during rotation.
Siemens Healthcare Diagnostics is recalling Dimension Vista Uric Acid assays because NAC and Metamizole can cause falsely depressed results.
Medtronic is voluntarily recalling battery packs for the Capnostream 20 and 20p patient monitors because they may experience thermal runaway, posing a potential fire risk.
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.
Stryker is recalling CinchLock Knotless Anchors after 13 reports of internal wire breakage upon deployment.
Hamilton Medical is recalling 1,115 Hamilton G5 ventilators because the ventilation pattern may not continue as expected after a suctioning maneuver.
C.R. Bard is recalling 2,613 Arctic Sun Temperature Management Systems because electronic components may cause the internal battery to drain prematurely, rendering the device unresponsive.
Novarad Corporation is recalling specific versions of NovaPACS Diagnostic Viewer because the PET/CT fusion tool calculates incorrect SUV values.
Covidien LLC is recalling Bravo pH capsule delivery devices due to a potential risk of allergic reactions in patients with nickel sensitivity.
FDA is recalling the Given Imaging Bravo pH capsule delivery device due to a potential allergic reaction risk for patients with nickel sensitivity.
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