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.
Philips C5-1 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Philips V6-2 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Philips X6-1 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Philips X7-2t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
Four boxes of HemoCue Glucose 201 Microcuvettes are being recalled because transit time fell outside limits, so stability through the microcuvette lifetime can no longer be guaranteed.
Philips L12-3 Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
ADVIA 120/2120/2120i SETpoint Calibrator lots are being recalled because they have the incorrect platelet value assignments for ADVIA hematology systems. 2,020 units are affected.
Philips S7-3t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
An interventional fluoroscopic x-ray system is being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
Philips S8-3t Transducers are being recalled because the ultrasound transducer devices were refurbished beyond their useful life. 5,230 units are affected.
ARTIS angiography systems are being recalled because a communication failure between the dose sensor and the software may cause the system to incorrectly report a high dose.
Onkos Surgical is recalling the My3D Personalized Solutions Humeral Cup, Model C24-0223-0003, because required inspections were not performed on finished product prior to release and distribution.
Philips Ultrasound, Inc. is recalling Philips C5-2 Transducers because they were refurbished beyond their useful life. The affected devices were distributed domestically nationwide and internationally across 49 countries.
Change Healthcare is recalling Cardiology Hemo Software (version 14.3.2 and 15.0.1) because a software update may cause the system to unexpectedly shut down. The recall affects 29 systems distributed across multiple US states and international locations.
Siemens Healthcare Diagnostics is recalling ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) units because they have incorrect platelet value assignments for the hematology systems.
Philips Ultrasound, Inc. is recalling 5,230 Philips L12-4 ultrasound transducer devices that were refurbished beyond their useful life. Affected units were distributed domestically and to numerous countries worldwide.
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System due to a software anomaly that can report test results using expired reagents even when the use-expired-reagents setting is disabled, potentially causing erroneous or delayed test results.
Philips Ultrasound, Inc. is recalling Philips XL14-3 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety during ultrasound examinations.
Eight Valeda Light Delivery Systems are being recalled because US customers were shipped devices configured for the European Union that could not be plugged into the outlet.
Becton Dickinson is recalling BD BACTEC MGIT 960 PZA Kit due to reports of intermittent false resistance results during pyrazinamide susceptibility testing of Mycobacterium tuberculosis. The issue affects units distributed worldwide.
Integra LifeSciences Corp. is recalling the MicroMyst Applicator Box of 5 due to lack of sterility assurance. The product is used with the Integra Flow Source for controlled application of two liquids.
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The recall affects 6,216 units distributed across the US and internationally.
Integra LifeSciences is recalling Extended Tip Applicator 8CM devices nationwide and internationally because they may contain potentially out-of-specification endotoxin levels and lack sterility assurance.
SunMed Holdings is recalling Broselow Pediatric Emergency Rainbow Tape due to incorrect values printed on the tape that could lead to improper medication dosing and defibrillation in pediatric emergency care.
Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.
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