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 5,576 units of the 8MM Horizon Small Clip Applier due to complaints of frayed or broken grip cables on the reusable instruments.
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits (Model 96-2478) due to packaging issues that may breach the sterile barrier and create contamination risk.
Sklar Instruments recalls ECONO STERILE medical procedure kits (300 units nationwide) due to packaging issues that may compromise sterile barrier integrity.
GE Healthcare recalls certain nuclear medicine systems that could have been transported without proper detector support, risking detector falls and life-threatening injury.
Intuitive Surgical is recalling 178 units of its 8MM Micro Bipolar Forceps (Model 470171) due to increased complaints of frayed or broken grip cables on the reusable instruments. Affected devices have been distributed nationwide and internationally.
Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.
Coloplast recalls Folysil Silicone Foley Catheters due to a possible sterility defect detected at the manufacturing facility. The affected units may not maintain proper sterilization, posing a risk of infection.
Intuitive Surgical is recalling 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on these reusable surgical instruments. Approximately 7,132 units have been distributed.
A software bug in BD Pyxis MedStation ES medication dispensing cabinets may prevent staff from locating alternate supply locations, potentially delaying patient therapy.
Alcon is recalling 41,718 units of its Monarch III D Delivery Cartridge due to a molding defect that could scratch the intraocular lens during cataract surgery.
Certain GE Healthcare nuclear medicine systems were potentially transported without proper detector support, risking detector fall and life-threatening injury. Affected facilities should have their equipment inspected before clinical use.
Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits nationwide due to packaging issues that may breach the sterile barrier. No injuries or illnesses have been reported.
Intuitive Surgical is recalling 42,028 Small Graptor surgical retractor instruments used with da Vinci X/Xi systems due to pitch cable failures. The recalled devices affect surgical facilities nationwide and internationally.
GE Healthcare's Discovery NM/CT 670 nuclear medicine imaging systems may have detectors that fall if not properly supported during transport or relocation, posing risk of life-threatening injury.
Intuitive Surgical is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments due to increased complaints of frayed or broken grip cables affecting reusable surgical instruments distributed nationwide and internationally.
Sklar Instruments is recalling ECONO STERILE gynecological dilator kits nationwide due to packaging issues that may breach the sterile barrier, potentially affecting product safety.
Intuitive Surgical, Inc. is recalling 8MM Force Bipolar surgical instruments due to increased complaints of frayed or broken grip cables on the reusable instruments.
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 recalls 355,547 monopolar curved scissors due to increased complaints of frayed or broken grip cables on these 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.
Augustine Temperature Management is recalling 817 units of its HotDog Patient Warming Temperature Management Controllers for a power-on self-test error code EA POST.
Box label states diameter 4,5 X 18,0 mm but actual implant is 4,0 X 18,0 mm. If dentist drills to box specifications, the smaller implant will not fit and may require revision surgery.
Intuitive Surgical is recalling 8MM Large Suture Cut Needle Drivers (Model 471296) due to complaints of frayed or broken grip cables. Affected instruments may lose functionality during surgical use.
Intuitive Surgical is recalling 8MM Mega Suturecut ND surgical instruments due to increased complaints of frayed or broken grip cables that may affect instrument operation.
Sklar Instruments is recalling ECONO STERILE ALFONSO INFANT SPEC STRL sterile surgical procedure kits nationwide due to packaging issues that may breach the sterile barrier.
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