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.
DeVilbiss Healthcare LLC is recalling 48 Model 7305P-D Powered Suction Units because a small percentage are experiencing premature failure during operation.
WalkMed Infusion is voluntarily recalling 12-inch Microbore Spike Sets due to the potential presence of particulate matter in or on the devices.
WalkMed Infusion is voluntarily recalling Triton Administration Sets because they may contain particulate matter. The recall affects 383 cases distributed nationwide.
WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter on or in the devices.
Parker Medical is voluntarily recalling Trach-Vac Endotracheal Tubes because they may kink during use, potentially affecting patient ventilation.
WalkMed Infusion is voluntarily recalling specific lots of IV administration sets due to the potential presence of particulate matter in or on the devices.
Roche Molecular Systems is recalling cobas EGFR Mutation Test V2 kits because internal studies found they may produce false negative results when used with the cfDNA Sample Preparation kit.
Smith & Nephew is recalling 563 TWINFIX QUICK-T Knot Pusher Suture Cutters because the sterile packaging may be breached.
WalkMed Infusion is voluntarily recalling specific lots of Triton IV administration sets due to the potential presence of particulate matter in or on the devices.
WalkMed Infusion is voluntarily recalling specific lots of T100-000VF IV sets due to the potential presence of particulate matter in or on the devices.
WalkMed Infusion, LLC is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.
WalkMed Infusion is voluntarily recalling T100-000F IV sets due to the potential presence of particulate matter in or on the devices.
WalkMed Infusion is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.
WalkMed Infusion is voluntarily recalling specific lots of 90-inch IV administration sets due to the potential presence of particulate matter in or on the devices.
WalkMed Infusion is voluntarily recalling specific lots of IV sets with 0.22 micron filters due to the potential presence of particulate matter in or on the devices.
WalkMed Infusion is voluntarily recalling Triton Administration Sets due to the potential presence of particulate matter in or on the devices.
Biomet, Inc. is recalling 5,458 units of the TSP Hip Fracture Plating System because screws may fracture during implantation, potentially leaving a foreign body in the patient.
RaySearch Laboratories is recalling RayStation radiation therapy software versions 3.0 through 5 due to incorrect biological clinical goal values for adapted plans.
Roche Molecular Systems is recalling two cobas Liat Analyzers released with incorrect default settings that may produce erroneous results.
WalkMed Infusion is voluntarily recalling specific lots of Triton IV administration sets due to the potential presence of particulate matter in or on the devices.
Centurion is recalling 483 convenience kits containing Medtronic light gloves with potential splits or holes that could transfer microorganisms to patients.
Carestream Health is recalling Touch Prime and Touch Prime XE ultrasound units because a software issue may cause anatomy volume measurements to be overestimated.
Beckman Coulter is recalling No Foam DxC reagent because it is incompatible with DxC hydropneumatic parts, potentially affecting UniCel DxC System analyzers.
Terumo CVS is voluntarily recalling HX2 Temperature Management Systems because the Interchlor sanitizer required for cleaning is no longer available.
Bayer Healthcare is recalling 42 MEDRAD MRXperion MR Injection Systems because they display a 4205 error message when used with 3T scanners.
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