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.
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
Karl Storz uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.
Edifier speakers in Draeger's Infinity Central Station may not produce audible alarms when in analog mode, potentially delaying patient treatment. Approximately 1,013 units are affected worldwide.
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Karl Storz is recalling 180 ureteroscopes due to instructions for use containing reprocessing procedures that have not been reviewed or approved by the FDA.
Medline procedure kits containing surgical masks are recalled nationwide because included masks failed to meet bioburden testing standards, creating potential infection risk during medical procedures.
Boston Scientific's AXIOS Stent Delivery System is being recalled because the outer sheath can detach during use, preventing proper stent expansion and requiring device exchange.
Percussionaire Corporation is recalling VDR4 Phasitron breathing circuit models due to a venturi component that may stick and reduce ventilation. This Class I recall affects over 4,700 units worldwide.
Olympus recalls 54,500 Thunderbeat surgical hand instruments due to probe tips that may be damaged or break. These sterile devices are used in ultrasonic surgical procedures.
Olympus is recalling Thunderbeat surgical hand instruments due to damaged or breaking probe tips that may occur during use and affect surgical procedure safety.
CareFusion 303 is recalling 5,056 BD Pyxis MedStation 4000 AUX units worldwide due to drawer and door failures that may delay medication access. Failures include door latch failure, cable ribbon damage, and magnet falling out.
Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.
Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US states.
CareFusion 303, Inc. is recalling 5 units of the BD Pyxis Med 4000 Auxiliary medication dispensing system due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.
Olympus is recalling approximately 9,200 units of Thunderbeat surgical hand instruments distributed worldwide because probe tips can become damaged, break, or pads can detach during use.
The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.
The Merlin.net Heart Failure monitoring application cannot transmit patient readings after a data migration to a cloud environment. Some systems (25 total) distributed across 13 U.S. states are affected.
Specific lots of BD PCR Cartridges used with the MAX System may experience signal drift, potentially affecting diagnostic accuracy. BD has initiated a recall of 516,435 affected units worldwide.
Medtronic Perfusion Systems is recalling EOPA Arterial Cannula models 77418 and 77422 due to incorrect labeling on seven manufacturing lots. Approximately 930 units were distributed worldwide.
VITROS XT 7600 Integrated System software may not warn users when Signal Reagent Packs expire, risking inaccurate or missing test results.
Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.
Baxter Healthcare is recalling specific lots of Clearlink System Solution Sets with inverted clamps that render the tubing unusable. The affected units are distributed nationwide in eight U.S. states.
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