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.
Diagnostic Hybrids, Inc. is recalling 26 units of the Quidel MicroVue Intact PTH EIA due to a potential loss of separation between calibrators that may impact assay calibration.
CooperVision is recalling specific lots of Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.
Medtronic is recalling 855 units of DxTerity Diagnostic Catheters because the outer box displays an incorrect 6 French size indicator, though the catheters inside are correct.
Ace Surgical Supply Co., Inc. is recalling six units of Double Blade Shoe F/Unigraft Knives because a single blade shoe was mistakenly packaged instead of the intended double blade.
CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.
CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.
CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.
Autochair is recalling Milford Smartbase units because a weak spring and misaligned locking pin caused legs to fold, dropping a person.
Philips is recalling 19 Brilliance iCT SP CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Cook Inc. is recalling 132 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.
Cook Inc. is recalling 2,267 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.
Philips is recalling 119 Brilliance Big Bore CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.
Philips is recalling Panorama 1.0T MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.
Philips is recalling 8,205 Multiva MRI systems worldwide due to a potential risk of helium gas release in the examination room during a magnet quench.
Draeger Medical Systems is recalling Infinity Acute Care System monitoring solutions because invasive pressure alarms may not activate.
Getinge is recalling 170 automated loading/unloading accessories for Washer-Disinfector 86 Series units due to a risk of disinfected goods falling to the floor.
Carefusion 2200 Inc is recalling 1,200 sterile thoracentesis and paracentesis kits because their packaging integrity may be compromised.
Life Technologies is recalling three lots of Human Fetal Hemoglobin FITC Conjugate because high background and unusual staining may cause false positive results.
Philips is recalling Ingenia 1.5T CX MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.
Philips is recalling the SmarthPath to dStream conversion software for 1.5T MRI systems due to a potential risk of helium gas release during a magnet quench.
Philips is recalling Brilliance 6 Slice CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.
NeuroLogica Corporation is recalling 16 solid state x-ray imagers because the retrofit equipment poses a potential foot injury risk during backward transport.
Philips is recalling 8,205 Multiva MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.
Philips is recalling 8,205 Intera 1.0T MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.
Philips is recalling 172 Ingenuity CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient load or unload.
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