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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.
GE Healthcare's Centricity Universal Viewer has a software defect where changes to radiological studies are not saved to archive systems, potentially affecting clinician access to current image data.
ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.
ZOLL Circulation is issuing a labeling update for its Premium Access Kit QUATTRO intravascular catheter kits due to potential leaks in the catheter or start-up kit tubing. This affects 1,253 kits distributed worldwide.
Johnson & Johnson is recalling TECNIS Eyhance intraocular lenses due to elevated endotoxin levels exceeding internal and FDA specification limits. Affected lenses were distributed nationwide in Illinois.
Philips Ultrasound recalls the Sparq diagnostic ultrasound system due to a battery system data issue causing intermittent device shutdowns, regardless of actual battery status or AC power connection. Affected units were distributed in 10 US states and internationally.
Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit when electromagnetic interference is present.
ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.
ZOLL Circulation is updating labeling for its QUATTRO Intravascular Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The update affects 1,733 units distributed worldwide.
ZOLL Circulation, Inc. is recalling the Solex 7 IV Disposable Pack and Start UP Kit due to potential leaks in catheter and tubing components. The Class II recall affects 79 bundles distributed worldwide.
Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.
Zoll Circulation recalls approximately 20,475 QUATTRO intravascular heat exchange catheter kits distributed worldwide due to potential leaks from the catheter or start-up kit tubing.
ZOLL Circulation recalls the ICY IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 42 bundles distributed worldwide.
ZOLL Circulation is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The recall affects 58 kits distributed worldwide.
Certain Philips Sparq ultrasound systems may experience intermittent shutdowns due to a battery system data issue, potentially interrupting diagnostic procedures. Affected units have specific serial numbers and distribution includes multiple U.S. states.
Flower Orthopedics is recalling 77 Flower E-Kit bone fixation kits because they are missing a required CDG 200 Cannulated Countersink component. The incomplete kits could compromise orthopedic surgical procedures.
Paltop Advanced Dental Solutions is recalling 337 Scan Abutment MU devices due to manufacturing tolerance deviations in orientation and sizing that may delay dental restoration procedures.
ZOLL Circulation is recalling approximately 1,122 ICY Heparin infusion kits distributed worldwide due to potential leaks in the catheter or start-up kit tubing. No illnesses or injuries have been reported.
FDA recalls 1,380 CardioQuip Modular Cooler-Heater 1000(i) devices worldwide due to labeling missing guidance on water-quality maintenance and device inspection procedures.
CardioQuip heater-cooler refrigeration modules used in operating rooms could develop bacterial contamination in water systems, potentially exposing patients to infection during surgery.
ZOLL Circulation is recalling 4,812 COOL LINE Intravascular Heat Exchange Catheter Kits worldwide due to potential leaks in the catheter or startup kit tubing.
ZOLL is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (188 units) addressing potential leaks from the catheter or start-up kit tubing.
Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.
Exactech is recalling knee implant system inserts that were packaged in vacuum bags lacking an oxygen barrier layer. This packaging defect may compromise product sterility and integrity.
CardioQuip is recalling 1,478 Modular Cooler-Heater devices because the labeling does not include proper water-quality maintenance and device inspection guidance.
ZOLL Circulation is recalling COOL LINE intravascular heat exchange catheters due to potential leaks in the catheter or start-up kit tubing that could affect their function during medical procedures.
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