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.
Roche Diagnostics is recalling Tina-quant sTfR assays due to updated claims regarding rheumatoid factor interference.
AZIYO BIOLOGICS is recalling CanGaroo Envelopes because sutures may become brittle or break before expiration. The devices are used to secure cardiac and neurostimulator implants.
Becton Dickinson is recalling BD Microtainer SST tubes because damaged reservoirs may cause insufficient sample volume and erroneous test results.
Centurion Medical Products is recalling Triple Lumen CVC kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate from the sealed surface after disconnection.
Centurion Medical Products is recalling OR VANTEX kits because the included BD MaxZeroNeedleess Connector may allow fluid droplets to separate after disconnection.
Centurion Medical Products is recalling CVC Insertion Bundles because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Centurion Medical Products is recalling CVC bundles containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the connector surface.
Centurion Medical Products is recalling UVC Trays containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the connector surface.
Centurion Medical Products is recalling Invasive Procedure Trays because they include a recalled connector that may release fluid droplets.
Becton Dickinson & Company is recalling BD Microtainer Z No Additive Tubes because damaged reservoirs may cause insufficient sample volumes and erroneous test results.
Centurion Medical Products is recalling CVC bundles containing a recalled BD connector due to potential fluid droplet separation.
GE Healthcare is recalling 22 AIR Technology Anterior Array MRI coils because the outer seam may separate, exposing porous internal material that cannot be disinfected.
Centurion Medical Products is recalling Neonatal Procedure Tray PICC Catheters because the included BD MaxZeroNeedleess Connector may release fluid droplets when disconnected.
Centurion Medical Products is recalling CVC Triple Lumen Safety Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.
Horiba Instruments is recalling ABX Pentra Lipase CP analyzers because triglyceride and cholesterol interference may cause false abnormal lipase results.
Centurion Medical Products is recalling 204 units of the CIRCLAMP W/1.3 CM BELL because a design mismatch may cause the clamp to remove foreskin without a scalpel.
Becton Dickinson & Company is recalling BD Microtainer PSTTubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.
Ohmeda Medical is recalling Giraffe Omnibed infant incubators because cleaning guidelines failed to prevent debris buildup, creating a potential infection risk.
Centurion Medical Products is recalling sterile cap change kits because they include a connector that may leak fluid droplets after disconnection.
Centurion Medical Products Corporation is recalling Neonatal Cap Change Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Centurion Medical is recalling central line bundles containing a BD MaxZeroNeedleess Connector due to the potential for fluid droplets to separate from the sealed surface after disconnection.
Becton, Dickinson and Company is recalling eight BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.
Becton, Dickinson and Company is recalling 30 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes, potentially affecting clinical decisions.
Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 tests because they may produce inaccurately low sample results.
Aziyo Biologics is recalling BioEnvelope surgical mesh envelopes due to possible suture brittleness or breakage along the seam before the expiration date.
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