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.
Medtronic is recalling the LINQ II Model LNQ22 Insertable Cardiac Monitor because it may fail to detect dangerous heart rhythms after a restart. The device was distributed worldwide.
GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.
C-RAD POSITIONING AB is recalling Catalyst positioning software c4D because it fails to properly update the Site field during synchronization in the setup workflow. This software defect may prevent correct system configuration.
Canon Vantage Tiitan 1.5T MRI Systems with certain serial numbers are recalled due to a component lacking proper flame retardancy, which could result in smoke or fire.
Cordis Corporation is recalling 680 Avanti® Catheter Sheath Introducer units because the actual product dimensions are larger than the labeling indicates.
GE Healthcare recalled 1,737 SIGNA Creator and SIGNA Explorer MRI systems due to a software bug where the 'Patient Orientation' button can be accidentally clicked instead of 'Save RX,' potentially causing incorrectly oriented diagnostic images.
GE Healthcare is recalling 1,519 Optima MR450w MRI systems worldwide due to a button interface error. The 'Patient Orientation' button may be unintentionally clicked instead of 'Save RX,' causing incorrectly oriented or flipped diagnostic images.
GE Healthcare is recalling 562 SIGNA Artist MRI systems due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of the Save RX button, potentially causing images to be incorrectly annotated or flipped.
RanD S.r.l. is recalling Ch24 round silicone catheters used in thoracic and abdominal cavity drainage due to a sterilization process quality issue. Some units in affected lots may not be sterile.
Arrow International is recalling 4 units of an electrode catheter marketed without FDA 510(k) clearance. The device was intended for electrophysiology studies.
Canon Medical System recalled its Vantage Titan 3T MRI systems due to a component lacking proper flame-retardancy standards. The defect could produce smoke or fire during use.
GE Healthcare recalls 311 SIGNA Architect MRI scanners due to button confusion that may result in flipped diagnostic images. The 'Patient Orientation' button may be accidentally clicked instead of 'Save RX', causing incorrect image orientation.
GE Healthcare is recalling 71 SIGNA PET/MR imaging devices worldwide. A software issue allows the Patient Orientation button to be accidentally clicked instead of Save RX, resulting in incorrectly annotated or flipped diagnostic images.
GE Healthcare recalls SIGNA Premier MRI scanners (100 devices, worldwide distribution) due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of Save RX, potentially resulting in incorrectly annotated or flipped diagnostic images.
HeartWare HVAD Pump Implant Kit (REF MCS1705PU) recalled because the pump's impeller shroud height does not meet the lower control limit. The device is used for hemodynamic support in patients with advanced heart failure.
Two lots of Aequalis Ascend Flex Shoulder System Reversed Tray components were swapped during distribution, resulting in packages containing components with incorrect thickness.
GE Healthcare's SIGNA MR355 and MR360 MRI systems are recalled due to a button UI issue that may cause diagnostic images to be flipped or incorrectly annotated. No patient harm has been reported.
GE Healthcare is recalling the SIGNA MR380 MRI system due to a user interface flaw where the Patient Orientation button may be inadvertently clicked instead of the Save RX button. This can result in incorrectly annotated or flipped MRI images.
Baxter Healthcare Corporation is recalling 4,752 units of EASYGRIP FLO-41 hemostatic delivery devices due to a discrepancy between the expiration date encoded in the 2D barcode and the human-readable date on the product.
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit (5 units) because it was marketed without FDA 510K clearance. Affected lot numbers: 16F20C0035 and 16F20F0124.
Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.
The Lingen Disposable Virus Sampling Kit by Mercedes Medical was voluntarily recalled due to lacking FDA 510(k) clearance. The recall affected approximately 11,711 boxes distributed nationwide and internationally.
Cardinal Health is recalling 13,426 units of Nonsterile Radial/Femoral Angiography Drape (Catalog #29529N) due to a manufacturing defect where plastic film causes the drapes to stick, preventing proper unfolding and application in surgical settings.
Luminex Corporation is recalling 17,110 units of the Verigene Gram Negative Blood Culture test (Model 20-006-021) due to potential false-negative results that may fail to detect Gram-negative bacterial infections.
Boston Scientific has recalled 5,920 VISIONIST CRT-P pacemakers due to hydrogen gas buildup that can compromise a capacitor and cause accelerated battery depletion. Affected patients should contact their healthcare provider for device evaluation.
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