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 Medical Systems Israel is recalling 38 MAXXUS systems because units past end of guaranteed service may have been moved without adequate detector support, risking a detector fall.
Repligen is recalling 33 MAVERICK Measurement Module Spectrometers because cable faults can drive laser output to about 1,600 mW or falsely signal a fire command.
Philips Medical Systems Nederland is recalling 990 Azurion R3.0 systems over nine identified software issues, including loss of X-ray after a pedal tap and continuous restart.
ICU Medical is recalling 64,290 Portex Spinal Trays because syringes may have a crack on the collar, which may lead to delayed or repeated blood draws and blood leakage.
GE HealthCare is recalling 12 units of the SMV BodyTrack nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.
Instrumentation Laboratory is recalling 7,720 units of a coagulation reagent used for evaluating the intrinsic pathway and monitoring heparin therapy over potential microbial contamination.
GE HealthCare is recalling 7 units of the SMV DSX New Line nuclear medicine system, because systems moved without adequate detector support may suffer a detector fall.
ICU Medical is recalling 64,290 Pulsator Arterial Blood Sampling Kits because syringes may have a crack on the collar, which may lead to blood leakage and repeated draws.
Canon Medical Systems is recalling 22 Vantage Titan 3T MRI systems because ice in the magnet venting system could lead to a helium vessel rupture during a quench.
Canon Medical Systems is recalling 34 Vantage Galan 3T MRI systems because ice may form in the venting system, and a quench in that condition could rupture the helium vessel.
Thoratec is recalling 8,399 CentriMag blood pump products after reports that the pump may not fit or lock securely into the motor using the screw-in locking feature.
Philips Medical Systems Nederland is recalling 10,466 Azurion systems on software versions R2.1.10 and R2.2.10 over six identified software issues including continuous restart.
Medline is recalling 41,432 laparoscopy convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medline is recalling 338 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Heraeus Medical is recalling PALACOS MV pro 40 and PALACOS MV pro 80 bone cement because an unfortunate combination of factors can leave ampoules unbroken, so no appropriate cement dough is formed.
Medline is recalling 4,536 procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.
Medline is recalling 16 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Philips Medical Systems Nederland is recalling 56 units of the Allura Xper FD10, model 722010, because the drip tray beneath the cooling unit may not have been installed.
Medline is recalling 11173 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Philips Medical Systems Nederland is recalling 18 units of the Allura Xper FD20 Biplane, model 722008, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 95 units of the Allura Xper FD10, model 722026, because the drip tray beneath the cooling unit may not have been installed.
Philips Medical Systems Nederland is recalling 4 units of the Allura Xper FD20/10, model 722029, because the drip tray beneath the cooling unit may not have been installed.
Medicrea International is recalling 44 IB3D PL Instruments Sets because, following complaints, the orthopedic rotation tool handle may untread from the shaft.
Medline is recalling 10 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
Medline is recalling 5314 units of kits containing B. Braun IV administration sets, which were recalled because check valve components may become stuck in the open or closed positions.
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