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.
Maquet is recalling 11 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
AtriCure is recalling 497 units of the EPi-Sense Guided Coagulation System because the sterile package seal may be compromised, posing a risk of infection.
GE Healthcare is recalling Centricity PACS-IW with Universal Viewer version 5.0 because medical images may be missing without warning.
Maquet is recalling 11 VOLISTA StandOP Surgical Lights because coating on the light head forks may crack, posing a risk of particles falling into the surgical field.
GE Healthcare is recalling specific ECG leadwire sets because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
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 two Thermo Scientific 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 six VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.
Thermo Fisher Scientific is recalling five Isotemp 10L General Purpose Water Baths due to an assembly error that may cause the fluid temperature to rise above the set point.
Thermo Fisher Scientific is recalling 12 General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to exceed the user's set point.
Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.
Medtronic is recalling 15 Hancock II T510 Mitral Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.
Medtronic is recalling 15 Hancock II T510 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.
Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with incorrect sizes. The actual valves are larger than indicated on the packaging.
Qiagen is recalling 31 units of the RNeasy DSP FFPE Kit because a contaminant in the deparaffinization solution reduces RNA purification efficiency.
Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.
Tecan US, Inc. is recalling 40 Freedom EVO 200 laboratory robots because gas springs were not always replaced within the specified interval.
Medtronic is recalling 15 Hancock II T510 Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.
GE Healthcare is recalling ECG trunk cables that may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
Teleflex Medical is voluntarily recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm connector may disconnect from the tube.
Cook Inc. is recalling 131 Advance Enforcer 35 Focal Force PTA Balloon Catheters because multiple complaints reported the balloons bursting below their rated pressure.
Monarch Medical Technologies is recalling EndoTool IV software versions 1.8 through 1.10 because insulin dosing calculations were erroneously high.
GE Healthcare is recalling 1,113 Discovery ML DR PET/CT systems because the table may stop moving without stopping X-ray exposure.
GE Healthcare is recalling 1,113 Discovery ML PET/CT systems because the table may stop moving without stopping X-ray exposure.
Teleflex Medical is voluntarily recalling specific lots of Sheridan Novaplus endotracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.
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