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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.
Medartis Inc. is recalling APTUS 2.8 TriLock Screws (lot 24377397) because some units are 16mm long instead of the specified 22mm, which could compromise bone fixation stability.
Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to manufacturing defects causing cerebrospinal fluid leakage from the catheter. Undetected leaks during implantation could result in infection risk to patients.
Philips Ingenia 1.5T MRI systems with software R5.7.1 may not provide adequate warning for low ventilation conditions, potentially causing increased patient body temperature or burning sensation.
TriMed Threaded IM Nail 3.6mm implants are being recalled due to a driver-socket defect that could prevent proper nail pickup or torque application. The recall affects 120 units from lot QM23087 distributed nationwide.
Medtronic recalls over 13,000 Left Heart Vent Catheter units due to potential for unsealed sterile packing. Affected devices distributed worldwide.
Medtronic Perfusion Systems is recalling multiple arterial cannula models worldwide due to potential for unsealed sterile packing. Compromised packaging may allow contamination of devices intended for clinical use.
Medtronic is recalling aortic root cannulae and cardioplegia needles used in cardiac surgery due to potential unsealed sterile packaging. Approximately 2,622 units were distributed worldwide.
Medtronic is recalling 5,719 vessel cannulae units due to potential for unsealed sterile packing, affecting worldwide distribution.
Ossur RHEO KNEE prosthetic units recalled due to firmware issues causing unintended warnings and device shutdown, which could result in patient falls.
QUIDELORTHO's VITROS Free T3 Reagent Packs may produce falsely elevated test results, potentially affecting thyroid function diagnoses and patient management. Eight lot numbers with expiry dates through August 2024 were distributed worldwide.
Philips Ingenia 3.0T MR systems with software R5.7.1 may fail to warn about low ventilation, potentially causing patient overheating or burning sensations. 19 units affected worldwide.
Medtronic Intracoronary Shunts may have compromised sterile packaging, potentially allowing contamination. The FDA Class II recall affects 1,410 units distributed worldwide.
Cook Medical has recalled EchoTip Ultra HD Endoscopic Ultrasound Access Needles (lots C2145003, C2144407) due to elevated levels of bacterial endotoxin. The devices were distributed internationally in Germany, Netherlands, Switzerland, and the United Kingdom.
Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to a manufacturing defect that causes cerebrospinal fluid leakage. An undetected leak during implantation could pose an infectious risk to patients.
Wishbone Medical recalls the WishFIX Growth Control Plating System because some units contain Stainless-Steel implants instead of the labeled Titanium implants. The recall affects 60 units distributed in Florida, New Jersey, and Connecticut.
Medtronic is recalling 500 units of Clearview Blower/Mister Model 22120 due to potential for unsealed sterile packing that could compromise device sterility.
Ossur H/F is recalling RHEO KNEE prosthetic knee components due to firmware issues that could cause unintended warnings and device shutdown, creating fall risk for users.
LeMaitre Vascular is recalling 5,604 units of Syntel Silicone Thrombectomy Catheters worldwide because the guide tip can become damaged and detach during use.
Certain HeartSine PAD defibrillators may fail to deliver voice prompts during emergency use due to a manufacturing defect, potentially delaying therapy. Visual instructions remain available.
Ossur is recalling 107 RHEO Knee XC prosthetic components due to firmware issues that may cause unintended device shutdown or warnings, risking patient falls.
Medtronic recalled 250 units of DLP Coronary Ostial Cannulae (Model 30050) due to potential unsealed sterile packing. Lot 2023070529 was distributed worldwide.
Karl Storz laser surgical instruments lack validated sterilization procedures, creating infection risk after reprocessing. The FDA has recalled 85 units distributed nationwide and in Argentina.
Philips Patient Information Center iX software version 4.x fails to properly save or transfer event catalog information, risking data loss in healthcare facilities. The FDA issued a Class II recall affecting 358 units globally.
Medtronic Perfusion Systems recalls 1,624 Disposable Pressure Display Sets (Models 61000 and 62000) distributed worldwide due to potential for unsealed sterile packing. No illnesses or injuries have been reported.
Medtronic is recalling seven models of cardioplegia adapters due to potential unsealed sterile packaging, which could compromise equipment sterility in cardiac surgery. No illnesses have been reported.
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