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.
Accuray is recalling 259 units of Ashland Box Film Ball Cube II calibration film because manufacturing defects may cause up to 0.5 mm of positional inaccuracy in CyberKnife systems.
Degania Silicone is recalling 1,025 Temperature Sensor Catheters because defective sensors may display lower body temperatures than actual patient readings.
Invivo Corporation is recalling 38 Xper Flex Cardio Physiomonitoring Systems distributed in the Netherlands due to incorrect firmware that may cause inaccurate ECG and heart rate displays.
Degania Silicone, Ltd. is recalling 4,372 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Polymedco is recalling 272 PATHFAST NTproBNP cartridges due to a manufacturing defect that may cause measurement values to be 12% to 20% higher than actual.
Exactech is recalling one unit of the Optetrak Logic CC Stem Extension because it may have non-conforming internal threads.
Mobius Imaging is recalling 147 AIRO Mobile CT Systems because a software fault prevents the tube current modulation feature from working.
Degania Silicone is recalling 11,488 temperature sensor Foley catheters because defective sensors may display lower body temperatures than actual.
Degania Silicone, Ltd. is recalling 100 units of temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.
Swissray Medical is recalling 27 ddR Formula B X-ray systems because the bucky component may move unexpectedly, posing a risk of injury to patients.
Degania Silicone is recalling Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Degania Silicone is recalling 500 sterile Foley catheters with defective temperature sensors that may display inaccurate readings.
Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.
Degania Silicone is recalling 500 temperature-sensing Foley catheters because defective sensors may display lower body temperatures than actual.
Leica Microsystems is recalling 160 surgical microscopes because the instrument may tip over when the swing arm is fully extended.
Degania Silicone, Ltd. is recalling 1,588 Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Degania Silicone is recalling 2,784 Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Degania Silicone is recalling 47,520 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than actual.
Degania Silicone is recalling 16,350 temperature sensor catheters because defective sensors may display lower body temperatures than actual.
Med-Mizer is recalling 230 PR1000 Pivot Rehab Beds because wires may become pinched during extreme left pivoting, requiring patient transfer until repaired.
Degania Silicone is recalling 1,028 temperature sensor catheters because defective sensors may display lower body temperatures than actual.
Stryker is recalling 243 IsoFlex LAL support surfaces because they were assembled with a non-conforming fire barrier. The units were distributed in five US states.
Degania Silicone is recalling 475 Temperature Sensor Foley Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
COVIDIEN LLC is recalling P400 temperature sensor catheters because they may display lower body temperature measurements than the patient's actual temperature.
Looking for a different category? Browse all recalls.