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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.
Waldemar Link is recalling 20 units of Modular Stem orthopedic implants due to incorrect GTIN labeling on the outer carton. The label bears a barcode for a different product.
A modular hip prosthetic stem (52 units) is being recalled due to an incorrect GTIN barcode on the outer carton label, which displays the code for a different product. No injuries have been reported.
Beckman Coulter recalls certain DxI 9000 immunoassay analyzers due to firmware issues that can cause communication failures, potentially delaying patient result reporting.
Microbiologics Inc is recalling Helix Elite Inactivated SARS-CoV-2 quality control material (Lot HE0065-29) because the A549 human cell target may produce late Ct values, potentially affecting test result validity.
Angiodynamics is recalling 1,800 units of IsoLoc prostate treatment balloons due to incorrect fill volume labeling. The affected devices were distributed nationwide.
Portex Endotracheal Tubes from Smiths Medical ASD, Inc. may have a smaller diameter than expected, potentially causing inadequate ventilation and patient hypoxia.
BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.
BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.
Medtronic is recalling 316,205 aortic root cannulas due to unexpected loose material in the male luer connector. If not identified before use, this defect could cause stroke; if identified, it may delay surgery.
Aesculap is recalling 1,147 hemostatic forceps due to clamp breakage risk when used beyond design specifications. Units were distributed nationwide and internationally to healthcare providers.
CardioFocus is recalling 833 units of CardiFocus Heartlight X3 cardiac catheters due to potential damage to the sterile barrier pouch that could compromise product sterility. Affected units were distributed worldwide.
ZOLL is recalling certain Powerheart G5 AED units that may fail their self-test when exposed to extreme temperatures or humidity. The affected devices could fail to function properly in emergencies.
ZOLL is recalling certain Powerheart G5 automated external defibrillators (AED) due to the potential for devices to fail their self-test when exposed to extreme temperatures or humidity.
TruAbutment Inc. recalls 61 units of the TruScan Body dental scanner (CN38-SB) due to defects that may prevent proper or accurate scanning.
GE Healthcare Revolution CT and Apex series imaging systems may leak blue coolant fluid near the gantry base, creating a potential slip and fall hazard. Approximately 250 units have been distributed worldwide.
DePuy Mitek is recalling COR Disposable Kit cartilage transplant systems because some units lack the pin in the graft loader component. The manufacturing defect may prevent proper device function during surgical use.
Cordis US Corp is recalling Vista Brite Tip guiding catheters manufactured at incorrect length. The defect may affect proper catheter placement during interventional or diagnostic vascular procedures.
Intuitive Surgical has recalled 439 Da Vinci 5 surgical console foot tray pedals due to spring failures that can cause pedals to remain pressed and interfere with normal surgical robot operation.
Aesculap is recalling 47,078 surgical forceps designed to control bleeding. The devices' clamps break when used outside design parameters, potentially compromising their effectiveness.
The ZOLL Powerheart G5 automated external defibrillator may fail its self-test after prolonged exposure to extreme temperatures or humidity levels. This could prevent proper device functioning in an emergency.
GE Healthcare Revolution CT systems may leak glycol coolant near the gantry base. While the non-toxic fluid poses no chemical hazard, it creates a slip-and-fall risk if not noticed and cleaned.
GE Healthcare is recalling 21 Revolution CT and Revolution Apex series CT systems due to potential coolant fluid leaks near the gantry base. The leaking fluid poses a slip-and-fall hazard if not cleaned up promptly.
ZOLL Powerheart G5 AED devices may fail their self-test if exposed to extreme temperatures or humidity. Approximately 56,981 units are being recalled nationwide and internationally.
Spectrum Medical is recalling Quantum Perfusion blood pumps due to potential fluid leakage during priming or clinical use. The issue affects approximately 1,487 units distributed nationwide.
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to a mechanical defect in the wash wheel mixer that may prevent the device from operating properly. The defect can cause test delays or cancellation.
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