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.
Bayer Healthcare is recalling PET Infusion Pumps used with the Medrad Intego system because they may fail pressure testing specifications when more than one year past the manufacturing date.
ICU Medical is recalling 100 units of Transpac transducer kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
ICU Medical is recalling 90 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
ICU Medical is recalling 430 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
ICU Medical is recalling 360 units of Cath Lab Kits for Genesis Health Care due to a potential leak in the SafeSet Reservoir and blood sampling kits.
ICU Medical is recalling 290 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
ICU Medical is recalling 40 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
ICU Medical is recalling 220 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
ICU Medical is recalling 60 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
ICU Medical is recalling 440 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
ICU Medical is recalling 30 units of Transpac pressure transducers and SafeSet reservoirs due to a potential leak.
ICU Medical is recalling 140 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
ICU Medical is recalling 30 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
ICU Medical is recalling 110 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
Roche Diagnostics is recalling specific Hemoglobin A1c test cassettes because they may produce erroneously high results.
ICU Medical is recalling 10 units of Transpac pressure kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
C.R. Bard is recalling 70 units of C-Max Cutting Loop Electrodes because the contact part could separate, affecting device functionality.
ICU Medical is recalling specific Transpac IV monitoring kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
ICU Medical is recalling 370 cardiac kits with 0.3 ml flush devices due to a potential leak in the SafeSet Reservoir and blood sampling components.
ICU Medical is recalling 30 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
ICU Medical is recalling Transpac IV Monitoring Kits because the SafeSet Reservoir and blood sampling components may leak.
ICU Medical is recalling 40 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
ICU Medical is recalling 80 units of Left Heart Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
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