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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.
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.
Stryker is recalling its CinchLock Flex Knotless Anchor due to an increase in pullwire breakage complaints. The broken pullwire may remain in the implant body after deployment.
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.
ZOLL is recalling Powerheart G5 AED devices that may fail their self-test when exposed to extreme temperature or humidity, potentially affecting proper device operation.
ZOLL is recalling 8,744 Powerheart G5 AED units that may fail their self-test if exposed to extreme temperatures or humidity, potentially masking device malfunctions.
Aesculap Inc is recalling 19,979 hemostatic forceps across 18 models because clamps can break when instruments are used outside of design specifications.
GE Healthcare is recalling Revolution CT and Revolution Apex series systems due to potential coolant fluid leaks from the gantry base, which could create a slip and fall hazard.
Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.
Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.
Medtronic MiniMed 720G insulin pumps may malfunction during airplane travel due to air pressure changes, causing abnormal insulin doses that can lead to severe low or high blood sugar emergencies.
Baxter Healthcare is recalling 66 units of Sigma Spectrum Infusion System (V6) due to potential missing motor mounting screws that may have occurred during servicing. Missing screws could affect the device's operation.
The Pipeline Vantage Embolization Device may malfunction, with the braid deforming or not positioning correctly, potentially causing blood clots. Approximately 7,820 units are affected worldwide.
Medtronic is recalling approximately 18,245 unused Pipeline Vantage embolization devices due to incomplete wall apposition and braid deformation that may lead to thrombosis and serious adverse events.
Baxter Spectrum IQ Infusion Systems may lack motor mounting screws due to a servicing defect. The FDA Class I recall affects 323 units distributed nationwide.
Biosense Webster is recalling VARIPULSE Bi-Directional Ablation Catheters (REF D141201) due to an observed trend of neurovascular events. The FDA issued a Class I recall affecting approximately 497 units distributed worldwide.
DeRoyal suction connector tubing in five U.S. states has been recalled because the connector's inner diameter is smaller than the suction canister lid port, making assembly difficult and risking inadequate suction and delayed patient care.
Kung Shin Plastics is recalling 30,000 units of CircuitGuard Bacterial/Viral Filter with Elbow (Model SK200FPE/7056) due to plastic occlusion in the connector that prevents airflow and causes ventilation bag malfunction, risking oxygen deprivation and respiratory distress.
MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.
Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.
Medtronic MiniMed insulin pumps can deliver abnormal insulin doses during air pressure changes in airplane travel, risking severe hypoglycemia or hyperglycemia and serious complications.
Medtronic MiniMed insulin pumps may deliver insulin abnormally during airplane take-off or landing due to air pressure changes, risking severe low or high blood sugar emergencies.
Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.
Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.
Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during airplane takeoff or landing due to air pressure changes, potentially causing severe low or high blood sugar.
Telcare recalls 34,764 Philips BGM 4 blood glucose meters (Model TM0009) nationwide due to battery expansion and swelling. The battery may cause the back cover to separate or, in worst-case scenarios, explode. No injuries reported to date.
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