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.
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.
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.
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.
NEOSTEO cannulated drill bits are being recalled due to corrosion traces on the laser marking that could release particles into the surgical field. The recall affects Lot 243-20 distributed in New Jersey.
Edwards Lifesciences is recalling Edwards PediaSat Oximetry Catheter Sets due to a potential for internal leaks that could affect proper device function.
Biomet recalled 10 units of Arcos hip implant components (lot 934870) nationwide due to potential inner taper corrosion and device failure that may require surgical intervention.
Edwards Lifesciences is recalling the Edwards PediaSat Oximetry Catheter Kit (REF: XT3515KTP) due to potential for internal leaks. The recall affects 70 units distributed across the US and internationally.
Stryker's S3 MedSurg hospital bed was distributed to home residents instead of healthcare facilities. The devices are designed for professional operation, and untrained home users may not understand safety instructions.
Exactech is recalling 29 BIOLOX delta femoral head hip prosthesis components due to a discrepancy between the product label and actual device marking. The mismatch could affect proper device identification and surgical placement.
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.
Cordis Corporation is recalling the SABER PTA Balloon Dilation Catheter due to potential contamination with foreign material from manufacturing. The contamination may transfer from the protective sheath to the balloon itself.
Biomet is recalling specific lots of Arcos Modular Revision Hip System cone bodies due to potential fretting corrosion and device failure that could require surgical intervention.
BioFire Diagnostics is recalling 29 FilmArray Blood Culture Identification Panel kits distributed nationwide due to false negative test results caused by a pouch manufacturing error.
Richard Wolf's Cutting Electrode Bipo 24.5FR may be mislabeled and contain a BIVAP electrode instead. Affected lot 21002858 was distributed to healthcare facilities in five states.
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.
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.
Beckman Coulter is recalling Access SARS-CoV-2 Antigen Calibrators because the assay test may generate false positive results, potentially leading to incorrect diagnosis. Approximately 451 units were distributed nationwide and internationally.
Merit Medical Systems recalls 760 units of Prelude SNAP Splittable Sheath Introducer (7F) due to packaging errors where devices are labeled as 10F instead of the correct 7F size.
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.
Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.
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.
Stryker has recalled 3 IsoGel Air pressure ulcer support surfaces that were distributed to home users when designed for use only in healthcare facilities. Home users may not understand the professional healthcare instructions required for proper use.
Stryker's S3 MedSurg hospital beds designed for healthcare facilities were distributed to home customers. The device labeling is correct but home users may not understand professional-use instructions, posing a risk of improper operation.
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