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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.
Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.
Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.
Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.
Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.
BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.
Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.
Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.
Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks within the catheters. The recall affects 178 units distributed across multiple US states and international locations.
Biomet is recalling Arcos hip prosthetic components that may develop corrosion and fail, potentially requiring revision surgery.
A medical stretcher designed for healthcare professionals was distributed to residential customers. The device labeling is appropriate for healthcare settings, but home users may not understand or follow the professional-use instructions.
BioMerieux is recalling MYLA microbiology software due to a software anomaly that could cause unwanted alterations to test results when using the BCI Connect scripting feature. 248 systems nationwide are affected.
Biomet is recalling 11 units of a hip replacement component that could experience inner taper corrosion and failure, potentially requiring surgical intervention. No injuries have been reported.
Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.
Stryker Medical recalls a surgical support tool that was distributed to home consumers but is intended only for healthcare professionals. The device labeling is correct, but home users may lack training to use it safely.
Biomet is recalling 22 units of Arcos hip implant cone bodies that may develop inner taper fretting corrosion, potentially causing device failure and requiring surgical intervention.
Biomet is recalling 81 units of a hip replacement component due to potential device failure that could require additional surgery. The affected device is the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A.
Dutch Ophthalmic USA is recalling TDC Vitrectomy Pack VGPC 25g surgical kits. The packages are labeled as containing 25-gauge infusion lines but actually contain 23-gauge lines instead.
QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.
Medline Industries is recalling 286 knee arthroscopy kits containing an expired NaCl irrigation bag. The kits should not be used due to the expired component.
A medical treatment recliner designed for healthcare facilities was distributed to home consumers. Home users may not understand the specialized instructions intended for healthcare professionals, creating a potential safety risk.
Biomet's Arcos hip implant replacement components may develop inner taper fretting corrosion, leading to device failure requiring surgical intervention. Seven units nationwide are affected.
Medline Industries is recalling 286 Arthroscopy Kits (REF DYNJ904304B) containing an expired NaCl irrigation bag component. The affected kits were distributed to Minnesota, Nebraska, and Pennsylvania.
Stryker's ComfortGel pressure injury treatment device was distributed to residential customers for home use, though it was designed for trained healthcare professionals. Home users may not understand the complex instructions intended for professional use.
Biomet is recalling 33 units of the Arcos Modular Revision Hip System due to potential inner taper fretting corrosion that could lead to device failure and require surgical intervention.
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