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.
Lap Chole Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 85 units are affected.
ROBOTIC PROSTATECTOMY PACK medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 24 units affected.
UniCel DxI 600 Access Immunoassay Analyzers are being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors. 271 systems are affected.
A DxI 800 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.
SafeStar 90 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's gas sampling port. 669,838 units affected.
SafeStar 60A Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 374,700 units affected.
HME TwinStar HEPA Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 1,019,782 units affected.
The Automated Impella Controller, used with left heart support blood pumps, is being recalled because of a potential issue with the controller not detecting an Impella pump when it is connected. 11,031 units affected.
SafeStar 55 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 9,885,139 units affected.
Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.
Achieva 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 460 units are affected.
MR 5300 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 551 units are affected.
Precision Sampling Sets for the CoSense End-Tidal Carbon Monoxide Monitor are being recalled because residual carbon monoxide may remain in the cannula filter, which may raise ETCOc scores. 2,160 units affected.
Celsior Cold Storage Solution is being recalled because of the potential risk of microbiological contamination due to an inability to ensure sterility assurance throughout aseptic manufacturing. 1,532 units affected.
LVP Primary Administration Sets, Single Outlet Low Sorbing, are being recalled because of the potential for external cassette leaks. 35,925 units are affected.
LIFEPEARL Drug Elutable Microspheres are being recalled because their actual average diameter is smaller than specification, which may lead to non-targeted embolization. 1,451 units affected.
Volcano Visions Digital IVUS Catheters are being recalled following reports of catheter and guide wire entanglement during radial-to-peripheral procedures, which may require surgical removal. 233,817 units affected.
Philips is recalling its Intera 3.0T Quasar Dual MRI system due to a potential fire hazard from gradient coil failures. The recall affects one unit distributed worldwide.
Ingenia Elition S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 242 units are affected.
Upgrade to MR 7700 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 26 units are affected.
Evolution Upgrade 1.5T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 93 units are affected.
HeartSine SAM 350P, 360P and 450P public access defibrillators are being recalled because a component manufacturing issue means the device may not function properly to deliver shocks. 190,516 units affected.
Ingenia 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 1,467 units are affected.
LVP Blood Products Administration Sets are being recalled because of the potential for external cassette leaks. 14,280 units are affected.
Philips Allura R8.2.x systems are being recalled because of the potential for temporary loss of imaging (X-ray) functionality due to a software issue. 4,508 units are affected.
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