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.
LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.
Spectranetics is recalling Turbo-Elite Laser Atherectomy Catheters because a marker band may become loose or disengaged when the device is used off-label.
LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have pinholes, creating a potential sterile barrier breach.
LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have pinholes, creating a potential sterile barrier breach.
Soft Computer Consultants is recalling SoftLab Software versions 4.5.4.3 through 4.5.5.20 because it may display lab results based on incorrect LOINC codes.
LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.
LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.
LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes that compromise sterility.
Stryker Neurovascular is recalling 43 Stroke Fast Packs because the carton sleeve labels did not match the physical contents inside the packs.
Quidel Corporation is recalling InflammaDry sample collectors because in-house testing found plastic spurs at the tips of some units.
Sentinel CH SPA is recalling MULTIGENT Creatinine (Enzymatic) reagents because Reagent 1 may cause quality control values to shift out of acceptable range.
Xintec Corp is recalling OptiLITE laser surgery products because reprocessing instructions may not meet new standards for cleaning and sterilization.
Stryker Neurovascular is recalling 48 Stroke Fast Packs because the pre-printed carton sleeve contents did not match the physical items inside.
Stryker Neurovascular is recalling 139 Stroke Fast Packs because the pre-printed contents on the carton sleeve did not match the physical contents of the pack.
Stryker Neurovascular is recalling 63 Stroke Fast Packs because the printed carton contents did not match the physical items inside.
Ortho Solutions Inc is recalling 277 units of Oxford/Oxbridge AFN End Caps due to material mislabeling. The affected devices were distributed to Maryland, New York, and Pennsylvania.
GE Inspection Technologies is recalling 13 Blade|line Industrial Cabinet X-ray systems because they exceed federal emission limits in an inaccessible crawl space.
Greatbatch Medical is recalling 11,360 MobiCath Bi-Directional Guiding Sheaths because one side of the pouch may not be sealed.
Maquet Datascope is recalling 12,319 CS 100i Intra-Aortic Balloon Pumps because electrical failures prevented the device from initiating therapy, which has been associated with a patient death.
Maquet Datascope is recalling 12,319 CS 100 Intra-Aortic Balloon Pumps because electrical and autofill failures prevented the device from initiating therapy, which has been associated with a patient death.
Maquet Datascope is recalling 12,319 CS 300 Intra-Aortic Balloon Pumps because electrical test failures caused the device to fail to pump, which has been associated with a patient death.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems because plastic fibers may allow excessive hydrogen peroxide to diffuse into the blood compartment.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems because plastic fibers may allow hydrogen peroxide to diffuse into the blood compartment.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems 3T because plastic fibers may allow hydrogen peroxide to diffuse into the blood compartment.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems 3T because plastic fibers may allow excessive hydrogen peroxide to diffuse into the blood compartment.
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