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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.
Sorin Group USA is recalling STOCKERT Heater-Cooler System 3T units because plastic heat exchanger fibers may allow excessive hydrogen peroxide diffusion.
Sorin Group USA is recalling 7,546 STOCKERT Heater-Cooler Systems 3T because plastic fibers may allow excessive hydrogen peroxide to diffuse into the blood compartment.
Invuity, Inc. is recalling 1,328 units of the INVUITY PhotonBlade device due to reports of unintended energy discharge that could cause tissue damage.
Medtronic Perfusion Systems is recalling DLP Extension Line Adapters because small pinholes were found in a single packaging configuration of sterile pouches.
Konica Minolta is recalling 36 Sonimage HS1 ultrasound systems because Doppler velocity measurements are not accurate.
Fisher Diagnostics is recalling Pacific Hemostasis FDP Assay Kits and Latex Reagents because reduced sensitivity may cause false negative results at low FDP levels.
Biomerieux Inc is recalling VITEK 2 Gram Negative test kits containing colistin because they produced high rates of major errors in susceptibility testing.
Fisher Diagnostics is recalling specific lots of Pacific Hemostasis FDP Latex Reagent because reduced sensitivity may cause false negative test results.
Medtronic Perfusion Systems is recalling DLP Pressure Monitoring Extension Line Adapters due to small pinholes in sterile packaging.
Medtronic is recalling DLP Antegrade/Retrograde Adapters because small pinholes were found in a single packaging configuration of sterile pouches.
Medtronic Perfusion Systems is recalling DLP Pressure Disposable Pressure Display Sets because small pinholes were found in the sterile packaging.
Atrium Medical Corporation is recalling specific iCAST and Advanta V12 covered stents because the catheter hub was printed with incorrect dimensional information.
Medtronic Perfusion Systems is recalling DLP Cardioplegia Adapters with Pressure Port because small pinholes were identified in a single packaging configuration of sterile pouches.
Cardinal Health is recalling specific lots of sterile surgical drapes because the outer labels do not match the packaged product inside.
Cardinal Health is recalling specific lots of Tiburon Arthroscopy Drapes because the outer labels do not match the packaged product.
Medtronic is recalling 214 units of the Visualase Cooled Laser Applicator System because the cap may fail to seal, causing saline leaks.
Smiths Medical ASD Inc. is recalling CADD Blue-Striped IV Administration Sets in Canada because the labels are missing expiration dates.
PerkinElmer is recalling 226 Sample Collection Devices because pack label serial numbers did not match the devices inside.
Flowonix Medical is recalling Prometra II implantable infusion pumps after a report of a fatal drug overdose during an MRI procedure.
Penumbra Inc. is recalling 155 units of the 3D Revascularization Device because a raw material issue could cause the delivery wire to break, potentially leading to serious injury or death.
Becton Dickinson is recalling 648,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet the Sterility Assurance Level.
Becton Dickinson is recalling 547,600 units of BD 10mL Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.
Pentax Medical is recalling 241 laryngeal strobe systems because isolation transformers were not always provided, posing a potential electrical safety risk.
Pentax Medical is recalling 241 units of 7245C, 7245C/E, and 7245D Computer Digital Video Systems because they may have been shipped without required 9175 isolation transformers.
Becton Dickinson is recalling 340,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.
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