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.
Becton, Dickinson and Company is recalling 21 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.
Vital Scientific N.V. is recalling 192 V-Twin automated chemistry analyzers because an improperly installed cooling indicator board may prevent warning signals if reagent cooling fails.
Centurion Medical Products is recalling VANTEX 7FR, 16CM, 3L CVC Bundles because the included BD MaxZeroNeedleess Connector may leak fluid droplets after disconnection.
Becton, Dickinson and Company is recalling 236 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with BD Trucount Tubes.
Centurion Medical is recalling CVC Bundle Multimeds containing a recalled BD connector due to potential fluid droplet separation.
Centurion Medical Products Corporation is recalling Central Venous Access Device Bundles because they include a connector recalled for potential fluid droplet separation.
Centurion Medical Products is recalling IV Start Kits containing a recalled BD connector due to potential fluid droplet separation.
Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 kits because they may produce inaccurately low sample results.
Becton, Dickinson and Company is recalling 78 BD FACSLyric Flow Cytometers because they may produce falsely high absolute counts when used with specific tubes, potentially affecting clinical decisions.
Centurion Medical Products is recalling Pediatric PICC Insertion Trays because they include a BD connector that may leak fluid droplets after disconnection.
Becton Dickinson is recalling BD Microtainer Tubes with K2E because damaged reservoirs may cause insufficient sample volume and erroneous test results.
Centurion Medical Products is recalling PICC Line Accessory Kits containing a BD connector that may release fluid droplets upon disconnection.
Centurion Medical Products is recalling Central Line Bundles containing BD MaxZeroNeedleess Connectors due to a risk of fluid droplets separating from the sealed surface.
Centurion Medical Products Corporation is recalling Sorbaview IV kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Becton Dickinson is recalling specific lots of BD Microtainer Tubes with Lithium Heparin because damaged reservoirs may cause insufficient sample volumes and erroneous test results.
Centurion Medical Products is recalling Pediatric PICC Insertion Trays because they include a BD connector that may release fluid droplets after disconnection.
Centurion Medical Products is recalling Cap Change Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Centurion Medical Products is recalling 1,530 Circlamps due to a design mismatch that may cause the device to remove foreskin without a scalpel.
BD Biosciences is recalling 36 BD FACSLyric Flow Cytometers because they may produce falsely high absolute cell counts when used with BD Trucount Tubes, potentially affecting clinical decisions.
Centurion Medical Products is recalling CVC Bundles because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Centurion Medical Products Corporation is recalling Infusa Port Kits containing a specific connector due to the potential for fluid droplets to separate from the sealed surface.
Centurion Medical Products is recalling 181,965 central line bundles nationwide because they include a connector that may leak fluid droplets after disconnection.
Centurion Medical Products is recalling Triple Lumen Bundle Kits because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Centurion Medical Products is recalling CAP CHANGE KIT DYNDC1496B because the included BD MaxZeroNeedleess Connector may release fluid droplets after disconnection.
Roche Diagnostics is recalling AssayTip/AssayCup Trays used on the cobas e 801 module due to abnormal internal structure that may lead to incorrect patient results.
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