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.
Baxter is recalling 1,225 Prismaflex Systems to communicate safety information regarding the proper use of connectors.
Boston Scientific is recalling MoXy Laser Fibers to update instructions and reduce the likelihood of metal cap and fiber tip breakage.
Stryker is recalling 40 units of Neptune E-SEP 165mm Blade Electrodes shipped to Canada because they were expired due to a distribution error.
Ortho Clinical Diagnostics is recalling VITROS TT4 Reagent Packs due to increased unsuccessful calibrations. The recall affects 3,181 units distributed in the US and 23 other countries.
Wilson-Cook Medical is recalling HEMO-10 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break, potentially causing the carbon dioxide cartridge to exit the handle.
Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.
bioMerieux is recalling PREVI Isola printer power supply units due to a potential fire hazard. The affected units are distributed worldwide.
Wilson-Cook Medical is recalling HEMO-7 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break during activation, potentially causing the carbon dioxide cartridge to exit the handle.
Acutus Medical Inc is recalling 268 units of AcQGuide Mini Fixed-Curve Introducers because manufacturing defects may have left foreign material on the devices.
Acutus Medical Inc is recalling 5 units of the AcQGuide Flex Steerable Introducer because manufacturing defects may have left foreign material particulates on the device.
Acutus Medical Inc is recalling 108 units of Rhythm Xience Guider Catheter Introducers because manufacturing defects may have left foreign material particulates on the devices.
Acutus Medical Inc is recalling 30 units of Rhythm Xience Flextra Steerable Introducers because manufacturing defects may have left foreign material particulates on the devices.
Beckman Coulter is recalling Opiate 300 Ng Reagent because cross-reactivity testing may not meet claims, potentially causing false positive or negative urine test results.
Alcon Research LLC is recalling 102 sterile procedure packs due to a potential mix-up with a 25-gauge infusion cannula.
Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters due to inadequate inspection of thermistor sensors.
Boston Scientific is recalling 5 units of Percuflex Plus Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
Boston Scientific is recalling Contour VL Ureteral Stent Sets due to an increased rate of complaints regarding difficulty tracking over the guidewire.
Boston Scientific is recalling 50 units of Stretch VL Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.
Smith & Nephew is recalling 125,196 Footprint Ultra PK Suture Anchors because packaging movement may displace the tip protector, creating a sterile breach.
Boston Scientific is recalling 91 Percuflex Plus Ureteral Stent Sets due to increased complaints about difficulty tracking over the guidewire, which may cause procedural delays.
Synaptive Medical Inc is recalling 28 units of ImageDrive Clinical software due to a defect that degrades mammogram image quality, potentially leading to misdiagnosis.
Biomet is recalling 125 units of Comprehensive Humeral Tray Taper Extraction Pliers replacement tips due to unknown bioburden levels that may affect sterility.
Boston Scientific is recalling specific lots of Sensor Nitinol Wire with Hydrophilic Tip because increased complaints indicate difficulty tracking over the guidewire, which may cause procedural delays.
Radiometer Medical ApS is recalling ABL90 FLEX PLUS Analyzers because the barcode reader may misinterpret labels, potentially causing patient mixups or lost samples.
Medivators is recalling Endo SmartCap Tubing because a manufacturing anomaly may cause inadequate insufflation, air bubbles, or water leaks during endoscopic procedures.
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