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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.
BioFire Diagnostics is recalling FilmArray GI Panel diagnostic kits due to temperature excursions during shipping that may reduce test performance.
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.
The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.
Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to a connection failure that may cause unexpected shutdown during use. The failure prevents communication between the device's display head and base unit.
The Cardiosave Hybrid intra-aortic balloon pump (IABP) is being recalled because it may unexpectedly shut down due to communication loss between internal components. The shutdown could interrupt therapy in cardiac patients and compromise their hemodynamic stability.
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.
Thirteen automated external defibrillators with incorrect language configuration have been recalled by HeartSine Technologies. The wrong language setting could delay or prevent therapy delivery in cardiac emergencies.
St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.
Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.
DiaSorin is recalling 4,142 Simplexa Flu A/B & RSV Direct Gen II diagnostic kits due to leaking Direct amplification Discs that may cause contamination, cross-contamination, invalid test results, and system error codes.
Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.
St. Jude Medical is recalling certain CardioMEMS heart failure monitoring devices due to excessive radiofrequency emissions that could interfere with pacemakers, defibrillators, and other implanted medical devices when in close proximity.
FDA recalls CardioMEMS HF System patient monitor for radiofrequency signal emissions that can interfere with pacemakers, defibrillators, and other implanted medical devices. The emissions exceed radiofrequency limits.
Boston Scientific's LATITUDE NXT system failed to display cardiac alerts for 1,531 patient records during 2022. Contact Boston Scientific to determine if your patients were affected.
Baxter MiniCap Disconnect Cap pouches may have faulty seals allowing air exposure, risking inadequate disinfection of the sterile connector used in peritoneal dialysis.
Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.
St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.
Select CardioMEMS CM2000 PA sensors may operate outside their intended frequency range above 2,000 feet elevation, potentially causing inaccurate readings or signal acquisition problems in heart failure monitoring.
CardioMEMS heart-failure monitoring devices are recalled due to radiofrequency emissions that can interfere with other medical devices like pacemakers when operating nearby.
DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.
Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.
A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.
Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.
Siemens is recalling 22,156 units of the epoc Host 2 blood gas analyzer due to pO2 measurement quality control issues related to barometric pressure. The devices are distributed worldwide.
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