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 CT 6000 systems, model 728307, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 6 units are affected.
Philips Allura Xper FD20/20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 75 units are affected.
The Philips Allura Xper FD20/15 OR Table is recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. One unit is affected.
Philips Allura Xper FD10 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 1,117 units are affected.
Philips Brilliance 16 Power, Brilliance CT 16 Slice and Brilliance CT 6 Slice systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 73 units are affected.
Voyant 1-Day Premium Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 90 units are affected.
Ortoma Inserter Adapter OTD devices are recalled because of a weld breakage between the pin and the inserter holder. 261 devices are affected.
BeneVision N1 Patient Monitors are recalled because of the potential for activation of an abnormal alarm pause. 2,278 units are affected.
Philips Brilliance CT 40 Channel, Brilliance CT 64 Channel and Ingenuity Flex systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 181 units are affected.
Philips Allura Xper FD20 Biplane OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 5 units are affected.
Philips Allura Xper FD20/10 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 45 units are affected.
Vasoview Hemopro 3 Endoscopic Vessel Harvesting Systems are recalled after out-of-box failures including deformed jaw attachments, jaws not fully closed and lifted heater wire. 98 units are affected.
Philips Ingenuity CT systems are recalled because the patient support table may descend unexpectedly to its lowermost position due to ball screw misalignment after a replacement. 285 units are affected.
Philips IQon Spectral CT systems, model 728332, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 81 units are affected.
Sofmed Breathables contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 180 units are affected.
Philips is recalling Brilliance iCT SP CT systems due to a ball screw misalignment that may cause the patient support table to descend unexpectedly to its lowest position.
MyDay Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 4,140 units are affected.
Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.
Philips Allura Xper FD20/20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 3 units are affected.
The t:slim X2 Insulin Pump with the Tandem t:slim mobile app is recalled because an app defect in right-to-left language settings causes pairing and graphical faults that could lead to incorrect therapy decisions.
Philips Ingenuity CT Family Brazil systems, model 728325, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 3 units are affected.
Philips Brilliance iCT systems, model 728306, are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 210 units are affected.
Philips Allura Xper FD10 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 2 units are affected.
Philips Allura CV20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 46 units are affected.
Philips Big Bore RT, Brilliance CT Big Bore Oncology and Brilliance CT Big Bore systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 33 units are affected.
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