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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.
Olympus is recalling its Inner Sheath Model A2642, a medical device used in urological procedures, after receiving complaints that the ceramic tip can break during use.
MRIMed Inc. is recalling 314 MRI LED Mobile Exam Light Batteries due to battery component overheating while charging, which can cause internal component melting and smoke.
Hitachi is recalling its Proton Beam Therapy system due to a software anomaly in the patient positioning system that may cause positional discrepancies during treatment.
Olympus recalls Model A2666 Resection Sheath for urologic use after receiving complaints of the ceramic tip breaking during procedures.
Olympus is recalling its Resection Sheath, 26 Fr, with Deflecting Obturator, model A22042T, used in urologic applications, after complaints that the ceramic tip can break.
Olympus is recalling Resection Sheath models A22014A and A22014T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.
Medline is recalling Meijer Sterile Saline Wound Wash First Aid Cleansing Spray because the manufacturer may not have made the product to the minimum sterility assurance level required for sterile products.
Olympus is recalling its Resection Sheath model A2666T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the sheath can break.
Medline is recalling Apheresis Subqport Access Kits and Central Line Insertion kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.
Medline is recalling certain Dialysis On/Off Kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.
Olympus is recalling its Resection Sheath, 28 Fr, model A22043A, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.
Olympus Corporation of the Americas is recalling Olympus Cystoscope Outer Sheath (Model WA22810A) because it may be incompatible with GreenLight Laser therapy, potentially damaging the device tip.
Medline is recalling seven convenience kits used for dialysis maintenance because the silicone seal on the Tego Connectors may dome or tear, which can occlude the fluid path.
Medtronic is recalling one lot of the Octopus Nuvo Tissue Stabilizer after identifying an assembly issue in which the short and long tubes were attached to the wrong ends of the canister.
Olympus is recalling its Sheath, 10 Fr, model A37004A, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.
Olympus is recalling its Resection Sheath, 24 Fr, with Deflecting Obturator, model A22041T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.
Medline is recalling Nail Kit convenience kits, model POD14214, because the manufacturer of the sterile saline wound wash they contain may not have met the required sterility assurance level.
Medline is recalling convenience kits containing Tego Connectors, sold as the Medline Dialysis Dressing Change kit, because the silicone seal may dome or tear and occlude the fluid path.
Olympus is recalling its Inner Sheath, model A2660, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the resection sheath can break.
Medline is recalling five Trunk Kit convenience kits because the manufacturer of the sterile saline wound wash they contain may not have met the required sterility assurance level.
Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040A, used in urologic applications, after complaints that the ceramic tip can break.
Encore Medical is recalling Reverse Shoulder Prosthesis humeral socket inserts, catalogue number 509-00-432, because knee and humeral socket implants contain incorrect labeling.
Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.
Olympus is recalling its Inner Sheath, Long, model WA22017A, used in urological and gynecological applications, after complaints that the ceramic tip of the resection sheath can break.
Olympus recalls 91 units of its Inner Sheath Model A4741 medical device after receiving complaints of the ceramic tip breaking during gynecological endoscopic procedures.
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