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.
Medical Components, Inc. is recalling Soft-Line Duo-Flow catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, or air emboli.
Medical Components, Inc. is recalling Duo-Flow Double Lumen Catheters because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
Siemens recalls RAPIDPoint 500 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
Medical Components, Inc dba MedComp is recalling specific hemodialysis catheter insertion kits because the suture wings may crack or break, posing a risk of patient injury.
Siemens is recalling 2,357 RAPIDLab 1265 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
Haemonetics is recalling OrthoPAT System-Integrated Sets because missing cannulas prevent blood from emptying, making the collected blood unusable.
Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Hip Procedure Tracking Kit because damaged reflective material may prevent camera detection.
Civco Medical Instruments is recalling 107 units of CIVCO Needle Guides because the assembly may lack sufficient adhesive to hold the cannula in place.
CSL Behring is recalling N Latex CDT Kits because they may produce inaccurate results that are approximately 15% lower than expected.
Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
Medical Components, Inc. is recalling specific hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.
Medical Components, Inc dba MedComp is recalling Soft-Line Duo-Flow Double Lumen Catheter Trays because suture wings may crack or break, posing a risk of patient injury.
Medical Components, Inc. is recalling hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.
Medical Components, Inc dba MedComp is recalling Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Sets because suture wings may crack or break, posing a risk of patient injury.
Medical Components, Inc. is recalling Duo-Flow IJ Full Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
Siemens Healthcare Diagnostics is recalling 138 RAPIDLab 1245 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.
GE Medical Systems is recalling 401 anesthesia systems worldwide because a gas switch may unexpectedly change position, potentially causing hypoxia.
Medical Components, Inc dba MedComp is recalling Duo Flow double lumen catheters because suture wings may crack or break, posing a risk of catheter dislocation, bleeding, and air emboli.
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
Baxter Healthcare is recalling FLOSEAL Special Applicator Tips because an incorrect plastic formulation was used in the blue luer component.
Tecan US, Inc. is recalling specific lots of the IBL International Cortisol Saliva Luminescence Immunoassay because the product generates cortisol values 1.3 to 1.8 times higher than the NIST standard.
Stryker is recalling Quikflap burr hole covers because the sterile packaging may become compromised after three years.
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
Medline Industries is recalling 90,870 units of 0.9% Sodium Chloride Injection due to incorrect overwrap packaging. The product is intended for flushing IV catheters and tubing.
Stryker is recalling QUIKFLAP cranial plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
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