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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.
Medartis Inc. is recalling APTUS 2.8 TriLock Screws (lot 24377397) because some units are 16mm long instead of the specified 22mm, which could compromise bone fixation stability.
Philips Ingenia 1.5T MRI systems with software R5.7.1 may not provide adequate warning for low ventilation conditions, potentially causing increased patient body temperature or burning sensation.
Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.
Hologic is recalling BioZorb Marker bioabsorbable surgical markers due to reported adverse events including infection, pain, device migration, and erosion. FDA classified this as Class I, affecting 53,492 units nationwide.
Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.
Vyaire Medical recalls Twin Tube sample line 240 cm devices (Model V-707327) due to potential nozzle separation during patient use. All lots manufactured prior to June 2023 are potentially affected.
Angiodynamics recalls 455 DURAFLOW 2 hemodialysis kits for loose metal shavings that could embolize, potentially requiring surgical removal.
GE Healthcare recalled certain Allia IGS and related fluoroscopic x-ray systems due to potential incomplete adhesive on bolts in the gantry assembly, risking detector or tube failure.
GE Healthcare is recalling certain Innova IGS x-ray systems due to potential adhesive defects on component bolts. Missing adhesive could cause the detector or x-ray tube to fall during use.
DURAMAX hemodialysis vascular access kits are recalled due to potential metal shavings that could enter the bloodstream and require surgical removal. Thirty units distributed in Virginia are affected.
GE Healthcare is recalling Allia IGS 7 interventional x-ray systems due to potential adhesive failure on bolts securing the detector and x-ray tube, which could fall during use.
DURAFLOW 2 vascular access kits for hemodialysis are being recalled because some units may contain loosely affixed metal shavings that could travel through blood vessels and potentially require surgical removal.
Angiodynamics recalls the Duramax Stacked Tip vascular access kit used for hemodialysis due to potential loose metal shavings that could enter the bloodstream and require surgical removal.
Angiodynamics recalled a vascular access catheter used for hemodialysis because it may contain loosely affixed metal shavings. These shavings could potentially detach and move through blood vessels, possibly requiring surgical removal.
Philips 5000 Compact Series ultrasound systems may leave unselected transesophageal transducers powered without temperature monitoring, risking patient burns during imaging procedures.
Angiodynamics is recalling 65 DURAFLOW 2 vascular access devices distributed in Virginia due to potential loose metal shavings that could enter the bloodstream and require surgical removal.
GE Healthcare is recalling certain Allia and Discovery IGS x-ray systems due to potential adhesive failure that could cause the detector, elevator, or x-ray tube to fall. No injuries reported.
GE Healthcare recalls Allia IGS and related interventional fluoroscopic x-ray systems due to potentially missing adhesive on bolts. The defect could allow the detector/elevator or x-ray tube in the gantry assembly to fall.
GE Healthcare is recalling x-ray imaging systems because adhesive on critical bolts may not have been applied, potentially causing the detector or x-ray tube to fall. The recall affects 21 units worldwide.
Angiodynamics has voluntarily recalled 285 units of DURAMAX STACKED TIP vascular access catheters (lots 5807195 and 5807196) used for hemodialysis. The specific reason for the recall is not disclosed in the FDA notice.
The DURAMAX STACKED TIP vascular catheter may contain loosely affixed metal shavings that could embolize and require surgical removal. Lot 5807208 affected, 15 units.
SPINEART's PERLA TL 25D spinal fusion screws are being recalled due to difficulties with setscrew insertion inside the screw head. The setscrew may not be properly tightened or may be positioned incorrectly, potentially affecting spinal stability.
Randox Laboratories has recalled Clinical Chemistry Calibration Serum (Cal2351/Cal10388) due to negative bias in inorganic phosphate measurements on RX Series instruments. The issue could affect the accuracy of clinical chemistry test results.
Angiodynamics Inc. is recalling DURAFLOW 2 vascular catheter kits used for hemodialysis and apheresis access due to potential metal shavings that may detach and travel through the vascular system, potentially requiring surgical removal.
Angiodynamics is recalling DURAMAX STACKED TIP medical devices that may contain loosely affixed metal shavings with potential to embolize, requiring possible surgical removal. The recall affects 50 units distributed in Virginia.
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