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.
AVID Medical is recalling Halyard SUTURE PACK CABG Cardiovascular Procedure Convenience Kits due to a raw material defect in the surgical needle coating that may reduce needle performance or cause coating removal during use.
Augmedics Ltd. is recalling the Perc Pin Adaptor, a component of the xvision Spine surgical navigation system, because the tightening knob is inconvenient to use and the tightening markings are improperly placed.
Meddev Corp is recalling Contour Gold Eyelid Weight implants (Model LL3010, 1.0 gm) due to mislabeling. The recall affects 34 units distributed nationwide across 17 states.
The CMS8000 Patient Monitor manufactured by Contec Medical Systems Co., Ltd. has nine identified cybersecurity vulnerabilities. The FDA is issuing this Class II recall affecting approximately 7,773 units distributed nationwide.
Richard Wolf GmbH is recalling 31 PiezoWave 2 Control Units (Product Number 100506US) due to a high voltage capacitor that may fail early in the device's life cycle, potentially producing smoke, burning smell, spark, or excessive heat.
Numed Inc is recalling BIB Balloon in Balloon Dilatation Catheter Model Number 420 due to incorrect labeling of balloon inflation hubs. The inner and outer balloon labels are swapped, which could lead to improper device use.
Beckman Coulter is recalling the DxC 500 AU Clinical Chemistry Analyzer due to a software error that prevents the analyzer from completing calibration orders under certain conditions, which can delay test result reporting.
Smiths Medical is recalling CADD-Solis VIP Ambulatory Infusion Pumps due to false Upstream Occlusion Alarms that may interrupt medication infusions, risking serious patient injury or death.
Smiths Medical is recalling CADD Solis HSPCA Pumps with wireless connection modules that may experience intermittent connection alarms, interrupting active infusions and risking serious patient injury or death.
Smiths Medical is recalling CADD-Solis and CADD-Solis VIP ambulatory infusion pumps because they may trigger a false upstream occlusion alarm that interrupts therapy, risking serious patient injury or death.
Bausch & Lomb is recalling enVista Envy and enVista Envy Toric intraocular lenses due to increased reports of toxic anterior segment syndrome (TASS) following implantation.
Integra LifeSciences is recalling CODMAN Craniotomy Kits due to inadequate welds that may cause the product to disassemble. The defect affects 1,840 units distributed worldwide.
Smiths Medical is recalling CADD-Solis infusion pumps worldwide due to a potential for thermal damage. The affected pumps include multiple models and variants distributed in the US and internationally.
Smiths Medical is recalling CADD Solis VIP Ambulatory Infusion Pumps due to potential thermal damage. The recall affects 313,676 units distributed nationwide and worldwide.
Bausch & Lomb has recalled multiple enVista intraocular lens models used in cataract surgery due to reports of toxic anterior segment syndrome (TASS) in the United States. TASS is an inflammatory reaction in the front of the eye following lens implantation.
Integra LifeSciences is recalling CODMAN Disposable Perforators (14mm) due to inadequate welds that could cause disassembly during use. The affected devices have been distributed worldwide.
Galt Medical Corporation is recalling certain Introducer Kit–Coaxial Dilator models due to potential open seals in sterile barrier packaging, which could compromise sterility.
Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System (Catalog Number 612802, Model BCL-100-04, Lot S25128171) due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.
Inari Medical is recalling 45 units of the Artix MT Thrombectomy Device (REF: 32-102, Lot 24100082) because labeling specifies an incorrect vessel range of 2.5-6 mm instead of 3-6 mm, which could increase radial force on arteries and cause vascular complications.
Galt Medical Corporation is recalling Introducer Kit-Tearaway MicroSlide devices used to introduce catheters into blood vessels due to a potential open seal in the sterile barrier packaging. The affected units may not maintain sterility, creating a risk of infection.
Galt Medical Corporation is recalling 2,881 GALT Centeze Catheters due to a potential open seal in the sterile barrier packaging. The open seal could compromise sterility of the device.
WANDERCRAFT SAS is recalling the Atalante X powered exoskeleton due to a potential loss of lateral balance that could cause patients to fall. Three units have been distributed to rehabilitation facilities in Pennsylvania and New York.
Philips is recalling Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines and related products because the adapter may be difficult or impossible to disconnect from the endotracheal tube.
Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 due to potential open seals in sterile barrier packaging, which could compromise product sterility.
Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits due to a potential open seal in the sterile barrier packaging. The affected kits are distributed nationwide in eight U.S. states and six countries.
Looking for a different category? Browse all recalls.