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.
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.
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.
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.
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.
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.
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.
GE Healthcare is recalling certain x-ray systems because adhesive material may not be properly attached to bolts, which could cause components to fall during use.
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.
Randox Laboratories is recalling 40 units of the Evidence MultiSTAT analyzer because a foam gasket defect may allow light to leak into the camera during testing, potentially affecting result accuracy and delaying reporting.
Stryker shipped 63 units of cranial mesh labeled as catalog 56-90614 (Gold) but actually containing 56-90314 (Blue) mesh. The mislabeling may cause procedural delays.
Thoratec HeartMate 3 left ventricular assist system implant kits may develop a leak at the seal interface between the inflow cannula and titanium apical cuff, potentially compromising device function.
Thoratec recalls HeartMate 3 left ventricle assist systems due to potential leaks at the seal interface. The FDA Class I recall affects 659 implanted devices worldwide.
RayStation 14.0.0.3338, a radiation therapy treatment planning system, may report source-to-surface distance (SSD) values as higher than actual measurements, potentially affecting radiation dose calculations. The FDA Class II recall involves 49 units distributed worldwide.
Zimmer recalled certain Periarticular Locking Plates due to a thread form defect that may prevent locking screws from properly seating. The defect may result in loss of fixation or delayed surgery requiring additional intervention.
RayStation versions 8.0.0.61 and 8.0.1.10 are subject to a Class II FDA recall due to a potential for calculated skin surface doses to be reported as too high. Healthcare facilities using these versions should contact the manufacturer for guidance and a corrective update.
Covidien is recalling 2,305 units of the Medtronic Invos Reusable Sensor Cable (PMAC71RSC) due to manufacturing defects in sensor cable connectors that may cause error codes or device malfunction.
IVOCLAR VIVADENT is recalling 2,472 units of IPS e.max ZirCAD CER/in. Prime dental material blocks because defects may cause cracks during sintering, risking fracture in the patient's mouth.
Cardinal Health is voluntarily recalling Jackson-Pratt 3-Spring surgical drain kits from specific lot numbers that were shipped unsterilized. Distributed worldwide including the US, the kits pose an infection risk if used without sterilization.
Zimmer orthopedic plates may have thread defects preventing locking screws from properly securing to the implant. This could delay surgery or cause loss of fixation requiring additional intervention.
RayStation 7.0.0.19, a radiation therapy treatment planning system, is being recalled due to potential source-to-surface distance (SSD) calculation errors that could affect radiation dose accuracy. The recall affects 14 units distributed worldwide.
Zimmer's Distal Lateral Fibular Plate has threading defects that may prevent screws from locking properly. The defect could go unnoticed during surgery and cause loss of fixation.
IVOCLAR VIVADENT AG is recalling 7,445 units of IPS e.max ZirCAD CER/in. Prime zirconium oxide blocks because they may crack during sintering, potentially causing dental restorations to fracture in patients' mouths.
RayStation radiation therapy planning software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 may calculate skin surface distance (SSD) values incorrectly, potentially affecting dose calculations. Affected software has been distributed worldwide.
Zimmer orthopedic plates may have thread defects preventing locking screws from properly mating, potentially resulting in loss of fixation and need for additional surgery.
Zimmer periarticular locking plates used in orthopedic surgery have a thread defect that may prevent proper locking of screws. The defect could delay surgery or result in loss of fixation requiring additional intervention.
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