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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.
DreamStation Auto non-continuous ventilators are recalled because the devices may carry a programming error resulting in an incorrect device configuration. The FDA classified the action as Class I.
Certain batches of the Carotid WALLSTENT Monorail Endoprosthesis are being removed after complaints of greater than anticipated resistance withdrawing the delivery system. The most serious potential consequence is stroke.
Abbott is recalling 53 HeartMate Mobile Power Unit AC power cords, model 107760, because a misaligned V-Lock may not engage and can allow an unintended disconnect. The FDA classified this as Class I.
Baxter is issuing an urgent correction for 36,705 Novum IQ large volume pumps because the pump may underinfuse when moving to a flow rate more than double the current one.
HeartMate Mobile Power Units are being recalled because misaligned V-Lock features on the power cords prevent the locking mechanism engaging properly and may cause unintended disconnect. 604 units affected.
DreamStation Auto BiPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 8 units are affected.
DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.
Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.
Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.
Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.
Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 55 45-S, lot 8-4266, are recalled because the screws may be incorrectly labeled.
FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.
High Pressure Tubing is being recalled because it may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 8,040 units affected.
Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 units are affected.
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze is being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.
3mensio Workstation (Vascular Fenestrated) software is being recalled because changing the 12h position of a single clock does not update other clock measurements, which may place stent graft fenestrations incorrectly. 501 units affected.
Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.
Custom Waste Management Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 858 units affected.
Carefree Surgical Specialties Kittner + Tail Large roll gauzes are being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 65 40-S, lot 8-4528, are recalled because the screws may be incorrectly labeled. 16 units are affected.
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze, catalog 15505/25 lot 1645, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 500 units are affected.
GE HealthCare is recalling 214 SIGNA Premier MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
GE HealthCare is recalling 330 Discovery MR750 3.0T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
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