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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.
Stryker Neurovascular is recalling Trevo ProVue devices due to manufacturing testing deficiency that may result in unsafe endotoxin levels and risk of fever, shock, or aseptic meningitis.
Agilent Technologies recalls Dako CoverStainer microscope slide stainers due to potential plexiglass door breakage that could cause injury.
A software upgrade to Philips Allura Xper FD20 Biplane systems causes the patient table pivot brake to fail to engage, potentially causing unexpected table movements during procedures.
CareFusion's BD Pyxis Anesthesia Station 4000 is recalled due to potential fluid ingress that may cause smoke, fire, or system downtime. The recall involves 11,875 units distributed worldwide.
Smith & Nephew is recalling OXINIUM Femoral Head components due to packaging containing incorrect product sizes compared to labels. The mismatch affects 23 packages distributed internationally.
CareFusion recalled 87,302 units of the BD Pyxis MedStation ES 7-Drawer Auxiliary Tower due to potential fluid ingress that could cause smoke, system downtime, or fire.
Stryker's FlowGate2 neurovascular devices may have excessive endotoxin levels because manufacturing failed to meet required testing standards. High endotoxin can cause fever, shock, and aseptic meningitis.
Lucid Diagnostics recalls EsophaCap esophageal diagnostic sponges due to risk of sponge detachment from string during device removal. No injuries have been reported.
CareFusion 303, Inc. is recalling approximately 71,569 BD Pyxis Anesthesia Station ES units worldwide due to potential fluid ingress that could cause smoke, system downtime, or fire.
Reflexion Medical is recalling the RefleXion X1 Radiotherapy System due to a potential dose error affecting patients treated with out-of-session SCINTIX partial fraction therapy. Seven systems were distributed across six U.S. states.
Stryker Neurovascular is recalling the Trevo Trak 21 Microcatheter due to potential endotoxin contamination from inadequate testing. High endotoxin levels may increase risk of fever, shock, and aseptic meningitis.
Philips is recalling Allura Xper FD10 medical imaging systems with software version 8.1.100 because the pivot brake may fail to engage, potentially causing unexpected table movements during procedures.
The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.
BD Pyxis MedStation ES medication cabinets may experience fluid ingress, potentially causing smoke, fire, or system downtime. CareFusion is recalling 212,367 units globally.
The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 units distributed worldwide.
Synthes surgical screwdrivers are being recalled because they lack a required relief cut and will not engage properly with 1.3mm and 1.5mm implant screws, potentially delaying surgery. The defect affects 261 units distributed in the US and Canada.
Stryker Neurovascular is recalling 81 neurovascular devices due to inadequate endotoxin testing. The devices may contain excessive endotoxin levels, which can cause fever, shock, and aseptic meningitis.
Covidien is recalling 1681 units of Tri-Staple 2.0 surgical staples due to potential cartridge damage that may result in poor staple formation and incomplete staple lines during surgery.
Stryker Mako robotic surgery software exhibits increased Error #3 when switching between surgical applications without system restart, resulting in treatment delays. No patient injuries reported.
Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.
Medline is recalling about 1.5 million Bed Assist Bar adult bed rails because users can become entrapped between the rail and mattress, posing a risk of asphyxiation. Two deaths have been reported.
BiPAP A40 ventilators may lose therapy delivery during a Ventilator Inoperative alarm, potentially causing respiratory failure or death in vulnerable patients.
Philips OmniLab Advanced + Ventilators may experience an alarm condition that interrupts or stops therapy delivery. This interruption may lead to inadequate breathing support, low oxygen levels, and potentially fatal respiratory failure.
Philips Respironics BiPAP A30 Ventilators may experience interruption or loss of therapy during a Ventilator Inoperative alarm, potentially causing severe respiratory compromise or death in vulnerable patients.
OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.
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