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.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying criteria stated in the manual.
Medtronic is recalling 10,448 Passive Biopsy Needle Kits because a manufacturing issue may cause depth stops to fail, potentially delaying surgery.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Volcano Corporation is recalling FFR software due to interoperability issues when connected to specific Hemodynamic Systems.
Young Dental Manufacturing Co, LLC is recalling Oral-B 5% Sodium Fluoride Varnish because the product shelf life may be shorter than indicated on the label.
DePuy Mitek is recalling 299 Healix Knotless ADV BR 4.75 Suture Anchors because they were manufactured with BIOCRYL material instead of BIOCRYL RAPIDE.
GE Healthcare is recalling Giraffe infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
GE Healthcare is recalling Giraffe OmniBed Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
GE Healthcare is recalling Giraffe Incubator Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
Lens.com is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because they may be counterfeit and have microbial issues.
Medtronic is recalling Synchromed II programmable pumps due to a potential foreign particle that could cause a permanent motor stall.
GE Healthcare is recalling Giraffe OmniBed infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
Stryker is recalling 16,380 disposable tourniquet cuffs because they may leak air, causing a loss of vascular occlusion during surgery.
Zimmer Biomet is recalling 34 units of 14MM Intramedullary Bone Saw Cam Assemblies because some were labeled as 14MM but measured as 13MM.
Steris Corporation is recalling 237 Evolution Loading Cars and Transfer Carriages because a locking pin defect may cause the equipment to fall forward unexpectedly.
CooperSurgical is recalling Quantum 2000 Electrosurgical Generators because they may stop cutting, coagulating, or blending during procedures when the foot pedal is used.
Steris is recalling 236 Eagle 3000 Small Steam Sterilizers because the preventive maintenance kit may contain an incorrect pressure safety valve.
Toby Orthopaedics is recalling PANTERA Proximal Humerus Fracture Plate Systems because suture clips may break during surgery.
CooperSurgical is recalling 105 Quantum 2000 Electrosurgical Generators because they may stop cutting, coagulating, or blending during procedures.
Allergan is recalling XEN Gel Stent implants because residual polishing compounds on the injector needle may transfer to the patient's eye, causing irritation or inflammation.
Zimmer Biomet is recalling 26 units of 13MM Intramedullary Bone Saw Cam Assemblies due to possible commingling with 14MM units.
Stryker is recalling 16,380 disposable tourniquet cuffs because they may leak air, causing a loss of vascular occlusion during surgery.
Philips is recalling 24,738 HeartStart XL+ Defibrillator/Monitor units because they may fail to turn on or restart, rendering them unable to return to a ready-for-use state.
Looking for a different category? Browse all recalls.