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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.
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.
Intuitive Surgical recalls 1,036 units of 8MM Micro Bipolar Forceps due to increased complaints of frayed or broken grip cables that could affect instrument function during surgical procedures.
Intuitive Surgical is recalling 8MM Tenaculum Forceps used with da Vinci X/Xi Surgical Systems due to pitch cable failures. These instruments are used for tissue manipulation and retraction during surgical procedures.
Sklar Instruments recalls ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. Affected units nationwide should not be used.
GE Healthcare is recalling Discovery NM/CT nuclear medicine imaging systems that may fail if transported improperly. Unsupported detectors risk mounting mechanism failure and detector fall, potentially causing life-threatening injury.
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 is recalling 859 units of nuclear medicine imaging systems that may have been transported improperly, risking detector failure and potential life-threatening injury from detector falls.
Intuitive Surgical is recalling 8MM curved bipolar dissectors due to frayed or broken grip cables that could affect surgical instrument performance. Approximately 3,869 units were distributed nationwide and internationally.
Intuitive Surgical is recalling approximately 46,759 8MM Force Bipolar IS4000 surgical instruments nationwide and internationally due to reports of frayed or broken grip cables that could compromise instrument function during surgical use.
The muRata Vios Monitoring System Model 2050 central station monitor can display distorted and flickering ECG waveforms and vital signs. The issue affects only the central station display, not the bedside monitor or patient monitoring accuracy.
Intuitive Surgical is recalling 11,162 units of 8MM Tenaculum Forceps (Model 470207) due to increased complaints of frayed or broken grip cables on reusable surgical instruments. Users should discontinue use immediately.
Sklar Instruments is recalling ECONO STERILE gynecologic biopsy procedure kits because of packaging issues that may breach the sterile barrier.
Cardinal Health is recalling 512,786 Laryngoscopy Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the United States, Canada, and Saudi Arabia.
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits due to packaging issues that may compromise the sterile barrier. The affected kits may no longer maintain their sterile condition.
Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.
IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty due to a polymer hydration defect that reduces product cohesiveness and moldability.
Intuitive Surgical is recalling 8MM Black Diamond Micro Forceps (Model 470033) due to complaints of frayed or broken grip cables. The defect affects 1,111 units distributed nationwide and internationally.
Sklar Instruments is recalling 350 strabismus surgical scissors kits nationwide due to packaging issues that may compromise the sterile barrier.
Sklar Instruments is recalling ECONO STERILE nail nipper and tissue nipper kits due to packaging defects that may compromise their sterile barrier. The affected kits were distributed nationwide.
Intuitive Surgical has recalled approximately 30,316 units of its 8MM Medium-Large Clip Applier instruments (Model 470327) due to reports of frayed or broken grip cables on the reusable surgical tools.
The Biocartis Idylla INSTRUMENT, an in vitro diagnostic device, has been recalled due to false-positive results in MSI-H testing. These false-positive results could lead to inaccurate diagnoses.
Intuitive Surgical is recalling 38,438 units of the 8MM Mega Needle Driver surgical instruments due to complaints of frayed or broken grip cables.
Sklar Instruments is recalling ECONO STERILE IUD Extractor kits (Model 96-4146A) due to packaging defects that may compromise the sterile barrier. Nationwide distribution.
Cardinal Health recalls Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Affected units were distributed in the US, Canada, and Saudi Arabia.
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.
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