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.
FDA Class II recall of Covidien Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft and remain in the patient.
Mindray is recalling 203 TD60 Transmitter battery chargers used with the BeneVision Central Station because a damaged circuit board can cause the battery to overcharge and the case to swell.
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
FDA is recalling specific lots of the Covidien Emprint Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering the desired microwave energy.
Bard Access Systems is recalling 53,699 PowerPICC Provena Catheters due to possible leaks at the luer hub extension leg junction.
Ecolab, Inc. is recalling Disposable Light Handle Covers because sterile packaging may contain gaps in the seal, potentially compromising sterility.
Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering microwave energy.
Philips Medical Systems is recalling BrightView X gamma cameras because collimators may drop to the floor during exchange, posing a physical hazard.
Philips is recalling 1,387 Precedence 6 imaging systems because collimators may drop to the floor during exchange, posing a risk of injury.
Medtronic is voluntarily recalling two lots of Vistec X-Ray Detectable Sponges due to possible contamination with human blood during manufacturing.
Philips Medical Systems is recalling BrightView Model 882480 gamma cameras because collimators may drop to the floor during exchange, posing a physical hazard.
Spacelabs Healthcare is recalling 12 Xhibit Telemetry Receiver systems because they may drop off the central station, causing a loss of patient monitoring.
Medtronic is recalling 2,914 custom perfusion systems because Terumo OPS valves may lack flow. The devices are used in cardiopulmonary bypass surgery.
Philips Medical Systems is recalling BrightView XCT gamma cameras because a collimator may drop to the floor during exchange, posing a risk of injury.
Panoramic Rental Corp. is recalling PC-1000 dental X-ray units because the lift motor may wear if not properly maintained, posing a risk of injury.
Microline Surgical is recalling ReNew Reusable Grasper and Dissector Tips because heat-shrink insulation may split during sterilization, posing a burn risk during surgery.
Angiodynamics, Inc. is recalling 14,353 Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering microwave energy.
Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators that may fail to deliver energy due to coolant ingress.
Brainlab AG is recalling 102 AIRO Mobile CT Systems due to a risk of unintended motion while the system is in transport mode.
Zimmer Biomet is recalling 1,524 non-sterile 1.0mm drill bits because a raw material anomaly may increase the risk of instrument fracture.
Philips is recalling 1,387 Precedence 16 imaging systems because collimators may drop to the floor during exchange, posing a physical hazard.
Philips Medical Systems is recalling 1,801 Brilliance 64 CT systems due to software issues in version 4.1.6.
ConvaTec is recalling a portion of Lot 7H02242 SUR-FIT Natura Moldable Durahesive Skin Barrier units that were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier.
Medical Components, Inc. is recalling 65 units of CT Port kits that were packaged with 21G needles instead of the labeled 18G needles.
Looking for a different category? Browse all recalls.