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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.
Philips is recalling the Intera 1.5T Power/Pulsar MRI system due to potential failure in the gradient coil component that could produce smoke and/or fire.
Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.
SunMed Holdings is recalling BreathTech manual resuscitators because the integrated manometer can leak, allowing patients to rebreathe exhaled CO2 during emergency airway management.
Convergent Dental is recalling 39 Solea laser surgical instruments due to potential unintended laser activation without foot pedal depression. No injuries have been reported.
Aizu Olympus has recalled 33 Mobile Airway Scope units due to an unvalidated air drying process. Some repaired units had wet channels, creating a potential risk of contamination and infection.
Philips is recalling SmartPath to dStream 1.5T MRI systems due to a potential gradient coil failure that could produce smoke or fire. The recall affects 119 units distributed nationwide and internationally.
DBX Demineralized Bone Matrix Putty units labeled as 10cc contain only 1cc of product, which may result in prolonged surgery. Affected units distributed in PA, TX, and WA.
Aizu Olympus is recalling Hysterovideoscope Model HYF-V units (27 devices) because the channel air drying process was not validated. Water remaining in device channels could pose an infection risk.
Aizu Olympus is recalling ultrasonic gastrovideoscopes due to an unvalidated channel drying process that left some scopes with water in the channels after repair. Water remaining in the device poses a risk of contamination and infection.
Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.
The ORION System robotic arm used in radiation therapy may suddenly accelerate or move unexpectedly when motion resumes after an interruption, creating a risk of collision with stationary equipment.
Aizu Olympus is recalling cystonephroscope endoscopes due to an unvalidated air drying process that allowed water to remain in instrument channels. Retained moisture poses a risk of contamination and infection.
Medtronic has recalled the Mo.Ma Ultra Proximal Cerebral Protection Device due to mislabeled manifold stickers. Both sides of affected units were labeled identically, potentially causing confusion about which ports control the proximal versus distal balloons.
Certain BD Extension Sets sold as free of DEHP (di(2-ethylhexyl) phthalate) actually contain this restricted phthalate. The products have been distributed worldwide.
SunMed Holdings is recalling Ventlab Horizon manual resuscitators due to a backwards leak in the integrated manometer that allows carbon dioxide rebreathing. The affected devices were manufactured from September 2018 to the present and distributed nationwide.
Sage Products is recalling approximately 174,960 Stryker Sage PrimaFit External Urine Management Systems in three lots because a small percentage may contain tape with undeclared natural rubber latex adhesive.
Philips is recalling Achieva 1.5T MRI systems due to potential gradient coil failure that could produce smoke and/or fire. Approximately 520 units have been distributed nationwide and internationally.
Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.
Boston Scientific is recalling EXALT Model D Single-Use Duodenoscopes due to fluid ingress in the lens, which causes poor image quality during procedures.
Sentinel CH SpA is recalling IRON assay kits (Reference Numbers 6K95-41 and 6K95-30) that may produce falsely elevated results. Affected lots could cause inaccurate iron measurements and delays in patient test reporting.
SunMed's Ventlab V-Care manual resuscitators are being recalled due to a backwards leak in the integrated manometer that allows CO2 rebreathing. Affected devices were distributed nationwide.
Aizu Olympus is recalling uretero-reno fiberscopes because the channel air drying process was not validated. A small percentage of repaired devices had residual water in the channels, creating a risk of contamination and infection.
SunMed Holdings recalls RescuMed manual resuscitators due to a backwards leak in the manometer allowing CO2 rebreathing. Affected models distributed nationwide across 32 US states.
Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs that may prevent surgical instruments from passing through properly. The defect may result in extended surgery time.
Aizu Olympus is recalling Hysteroscope Model HYF-1T devices because the channel air drying process after repair was not validated. Some returned units had residual moisture that could allow contamination and infection.
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