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.
Philips Healthcare is recalling 16 Juno DRF X-ray systems because fluoroscopy dose values may not display correctly at the operator's position.
Ortho-Clinical Diagnostics is recalling VITROS Vapor Adsorption Cartridges because some cartons incorrectly contain Particulate Cartridges, which may bias test results.
Siemens Healthcare Diagnostics is recalling Dimension IRON Calibrators because some lots produced calibration results outside acceptable ranges.
Alere San Diego, Inc. is recalling 614 kits of Cholestech LDX Calibration Verification due to out-of-range HDL cholesterol results.
Alere San Diego, Inc. is recalling Alere Cholestech LDX Multianalyte Control kits because they may produce out-of-range HDL cholesterol results.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling 36 units of VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER polyaxial screws because the shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.
DePuy Spine is recalling VIPER Polyaxial Screws 8x80mm and larger because the screw shank may separate from the head during high-torque insertion.
ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling UltraClean Accessory Electrode 4 inch Coated Blades because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling 313,190 ABC Nozzles because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling 313,190 Electrosurgical Tip Cleaners because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling Goldvac UltraClean Accessory Electrode Blades because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.
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