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.
Intuitive Surgical is recalling 38,438 units of the 8MM Mega Needle Driver surgical instruments due to complaints of frayed or broken grip cables.
Cardinal Health Presource surgical kits and dental packs are recalled due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units were distributed worldwide.
Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.
ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.
GE Healthcare nuclear medicine systems including Infinia II Hawkeye 4 may have been transported without proper detector support, risking detector failure and serious injury.
Sklar Instruments is recalling ECONO STERILE dental cement spatulas (Model 96-2245M) due to packaging defects that may compromise the sterile barrier. The product was distributed nationwide.
A software defect in Change Healthcare Cardiology Hemo software may cause clinicians to administer incorrect medications. The defect affects the autosave mechanism in affected versions.
Cardinal Health Presource surgical kits used in aneurysm procedures may contain endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units distributed worldwide; no illnesses reported.
Intuitive Surgical is recalling 5,576 units of the 8MM Horizon Small Clip Applier due to complaints of frayed or broken grip cables on the reusable instruments.
Augustine Surgical temperature management controllers (Models WC71, WC77, and MP 2083516) may experience a power-on self-test error code. Seventeen units have been recalled worldwide.
Sklar Instruments is recalling 1,050 units of ECONO STERILE Vein Hooks due to packaging issues that may breach the sterile barrier. Products were distributed nationwide.
Intuitive Surgical is recalling 147,006 units of 8MM Fenestrated Bipolar Forceps due to increased complaints of frayed or broken grip cables, which could impair surgical control.
Intuitive Surgical is recalling 68,458 units of its 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on the reusable surgical instruments.
Intuitive Surgical is recalling its 8MM Tip-Up Fenestrated Grasper due to frayed or broken grip cables on reusable surgical instruments. The defect affects multiple batch numbers produced between 2023 and 2024.
ConvaTec's Esteem Synergy Stomahesive Skin Barrier packages may contain pre-cut wafers of 28mm instead of the labeled 16mm or 35mm, potentially causing skin abrasion or bleeding during use.
Sklar Instruments is recalling ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. The kits were distributed nationwide.
Cook Biotech is recalling specific Cook Medical Biodesign Dural Graft devices due to incorrect expiration dates on two units and use of an incorrect Instructions for Use version.
Cook Biotech is recalling 6 hiatal hernia grafts (Lot #LB1579758) due to incorrect Instructions for Use and wrong expiration dates on two units.
Cook Medical is recalling 49 Biodesign Otologic Butterfly Graft surgical implants due to incorrect Instructions for Use version and incorrect expiration dates on product packaging. No illnesses or injuries have been reported.
DRG International is recalling the DRG:HYBRiD-XL Insulin device (Model HYE-5361) due to calibration failures and out-of-specification controls that may delay assay results.
IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty bone graft materials due to a hydration issue that makes the product less cohesive and moldable than intended.
IsoTis OrthoBiologics recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration dates on outer packaging. The outer box date does not match the correct date on the inner tray.
The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.
Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.
Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.
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