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.
Vyaire Medical is recalling enFlow Disposable Cartridges with IV Extension Sets because testing showed aluminum elution during fluid warming.
Becton Dickinson is recalling SmartSite Syringe Administration Sets because they may leak, potentially interrupting infusions or exposing healthcare workers to fluids.
Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.
GE Healthcare is recalling 58,045 replacement ECG leadwires worldwide because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
Collins Aerospace is recalling TASE 500 Imaging systems because the Nominal Ocular Hazard Distance for the alignment laser was miscalculated.
Thermo Fisher Scientific is recalling Isotemp 20L General Purpose Water Baths due to assembly errors that may cause the fluid temperature to exceed the user's set point.
Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.
Thermo Fisher Scientific is recalling four General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.
Maquet is recalling 12 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling 46 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, risking particle contamination in the surgical field.
GE Healthcare is recalling 292 units of the Centricity Universal Viewer because it may fail to warn users when medical images are missing from exams.
Maquet is recalling 9 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
Maquet is recalling 7 units of VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.
GE Healthcare is recalling ECG leadwire sets because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.
Thermo Fisher Scientific is recalling three General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.
GE Healthcare is recalling 58,045 replacement ECG leadwires because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.
Maquet is recalling 65 VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field and causing patient infection.
Thermo Fisher Scientific is recalling four Thermo Scientific General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the set point.
Maquet is recalling 10 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, potentially dropping particles into the surgical field.
Thermo Fisher Scientific is recalling 10 Fisher Scientific Isotemp water baths because an assembly error may cause the fluid temperature to rise above the user's set point.
Hitachi is recalling three PROBEAT-V proton therapy systems due to a potential software error that could result in incorrect target positioning during treatment.
Thermo Fisher Scientific is recalling four units of the General Purpose Dynamic Bath due to an assembly error that may cause the fluid temperature to rise above the user's set point.
Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head fork coating may crack, posing a risk of particles falling into the surgical field and causing patient infection.
Maquet is recalling five VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
Collins Aerospace is recalling 433 TASE 400 Imaging systems because the Nominal Ocular Hazard Distance for the alignment laser was miscalculated.
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