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.
OMM Imports' Recreo Hair Growth Laser Comb is being recalled because 1,620 units lack required safety labels, warnings, and certification documentation. Missing labels create risk for users of the Class 3R laser device.
Becton Dickinson is recalling 45,000 units of BD Ultra-Fine Insulin Syringes (catalog 326679, lot 2164338) due to nonsterile manufacturing that could expose patients to pathogenic microorganisms and local infection. Distribution was worldwide.
Scientia Vascular is recalling Plato 17 Microcatheters due to manufacturing defects that may introduce loose particles into the catheter lumen, potentially causing blood vessel blockage or inflammatory reactions.
Intuitive Surgical recalls Patient Side Carts for da Vinci X and Xi surgical systems due to ballscrew failure risk. The failure could cause uncontrolled carriage movement leading to potential tissue injury during surgery. 9 units affected.
Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test results.
BD Insulin Syringes (Catalog 329420) are being recalled due to nonsterile conditions that could expose patients to pathogenic microorganisms and increase infection risk. The recall affects 961,000 units distributed worldwide.
Fenwal Inc is recalling 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.
BioFire Diagnostics is recalling BioFire BCID2 diagnostic panels that experienced temperature excursions during shipment, which may reduce their performance. Affected kits were distributed in Florida and Georgia.
BioFire Diagnostics is recalling FilmArray GI Panel diagnostic kits due to temperature excursions during shipping that may reduce test performance.
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.
The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.
The Cardiosave Hybrid intra-aortic balloon pump (IABP) is being recalled because it may unexpectedly shut down due to communication loss between internal components. The shutdown could interrupt therapy in cardiac patients and compromise their hemodynamic stability.
Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to a connection failure that may cause unexpected shutdown during use. The failure prevents communication between the device's display head and base unit.
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.
DiaSorin Molecular's Simplexa COVID-19 Direct test kits may leak, potentially causing contamination and invalid test results. The FDA has issued a Class II recall affecting approximately 90,142 units distributed nationwide.
LetsGetChecked Blood Sample Collection kits were distributed with incorrect shipping labels that assigned samples to wrong users. This could result in incorrect Hepatitis C Virus test results or rejected samples due to demographic mismatches.
St. Jude Medical is recalling the CardioMEMS HF System (Model CM3000) due to excessive radiofrequency emissions that may interfere with pacemakers, defibrillators, and other implanted devices during use. The recall affects 1,905 units distributed worldwide.
Sensus Healthcare recalls 23 units of the SRT-100 Vision superficial X-ray radiation therapy system due to a software dose timer malfunction that may result in unexpected radiation delivery to patients.
Thirteen automated external defibrillators with incorrect language configuration have been recalled by HeartSine Technologies. The wrong language setting could delay or prevent therapy delivery in cardiac emergencies.
St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.
St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.
FDA is updating labeling for Sprint 200 wheeled stretchers to ensure the siderail is secured to a locked position, preventing potential patient falls and injuries. 335 units (310 US, 25 international) are affected.
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.
Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.
Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.
Looking for a different category? Browse all recalls.