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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.
Becton, Dickinson and Company is recalling one lot of BD Retic-Count Reticulocyte Reagent System because the carton label listed incorrect storage conditions.
Vascular Solutions is recalling Guardian II Hemostasis Valves because the low-pressure seal may fail, potentially allowing air into the device and causing an air embolism.
Focus Diagnostics is recalling Simplexa HSV 1&2 Direct Amplification Discs because they may cause false negative or positive results and error codes.
Focus Diagnostics is recalling Simplexa Group A Strep Direct Amplification Discs because they may cause false test results or error codes.
Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, potentially compromising the device's structural integrity.
MicroAire Surgical Instruments is recalling 37 units of the PAL-R4011XL French Rasp aspiration cannula because they bent or broke during surgery.
ScottCare is recalling 9,067 TeleSentry batteries after a complaint that one exploded while recharging. The batteries are used in cardiac monitoring devices.
Therakos Inc is recalling 729 units of the CELLEX Photopheresis System, Lot D342, due to an increased trend in tubing leaks within the pump tubing organizer.
AngioDynamics is recalling 136 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended 0.038-inch guidewire.
Fresenius Medical Care is recalling 1,650 Hemoflow F3 Dialyzers due to a potential header leak caused by improper torque.
Philips is recalling eValueMed infant heel warmers and transport mattresses because they lack expiration dates and warnings about overheating risks.
AngioDynamics is recalling 100 Renown Regional Medical Center Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a wiring error may leave a module energized when the power cord is unplugged.
AngioDynamics is recalling 45 NAMIC Convenience Kits because the needle inner lumen may be too small to accept a 0.038-inch guidewire.
Philips is recalling eValueMed Infant Heel Warmers and Transport Mattresses because they lack expiration dates and warnings about overheating risks after shelf life.
Synthes (USA) Products LLC is recalling specific lots of Titanium Low Profile Neuro Screws because the thread height is undersized, which may affect the device's structural integrity.
GE Medical Systems is recalling 16 SIGNA Pioneer MR systems because ferrous material in the Table Control Box could cause unexpected attraction to the magnetic field during servicing, posing a risk of serious injury to personnel.
Focus Diagnostics is recalling Simplexa Direct Amplification Discs because they may cause false test results or error codes.
Laserex Systems Inc. is recalling 74 Ellex Medical Fixed Eye Safety Filters due to a design error in the optic adaptor that may compromise eye protection.
MicroAire is recalling PAL-R4011XL cannulas because three reports indicated the devices bent or broke during surgical procedures.
AngioDynamics is recalling 8 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.
Applied Medical Resources is recalling specific Epix Universal Clip Applier kits due to a potential loading mechanism nonconformance.
Cardinal Health is recalling Gomco Style Circumcision Clamp Trays because two lots were labeled as containing 1.1cm clamps but actually contained 1.3cm clamps.
Biomet, Inc. is recalling 576 units of Prelude PF Resurfacing Knee System instrumentation due to inadequate design control. The products were distributed to 12 US states.
Siemens Medical Solutions is recalling 49 PACS systems because they may display incorrect distance measurements when used with certain modalities and syngo Imaging.
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