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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.
Datascope is recalling 47 Cardiosave Rescue Intra-Aortic Balloon Pump systems to issue an instructions for use addendum revising the preventative maintenance schedule.
Fresenius Kabi USA is recalling 483 cases of Ivenix LVP Primary Administration Sets after incorrect assembly of a specific lot that the firm states could result in serious patient injury.
Get Tested International AB is recalling 40 units of its Urinary Tract Infection Test because the product was distributed without premarket approval or clearance.
Philips North America is recalling the IntelliVue Patient Monitor MX550 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP80 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX800 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP2 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP50 over a potential issue where the monitors did not alarm.
Illumina is recalling 11,916 NextSeq 550Dx reagent kits because flow cell gaskets have a quality issue that may cause leaks during runs, including possible toxic substance exposure to the user.
Enterix is recalling 201,426 InSure ONE Fecal Immunochemical Test kits after the test failed sensitivity testing with one test card lot, which may result in false negative results.
Philips North America is recalling the IntelliVue Multi Measurement Server X2 over a potential issue where the monitors did not alarm.
Medtronic is recalling 6,591 Aurora EV-ICD and Clinical EV-ICD single chamber extravascular defibrillators over the potential for delayed time to high-voltage therapy in a rare sequence of events.
Philips North America is recalling the IntelliVue MP90 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP20 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Multi-Measurement Module X3 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX850 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP5 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX750 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX400 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP60 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX500 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP30 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue MP70 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX100 over a potential issue where the monitors did not alarm.
Philips North America is recalling the IntelliVue Patient Monitor MX600 over a potential issue where the monitors did not alarm.
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