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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.
Siemens Medical Solutions is recalling 1,301 SOMATOM Sensation 10 CT scanners due to a software error that may cause unnecessary radiation exposure during head scans.
Cook Inc. is recalling 38,542 StoneBreaker C02 Cartridges because the interior may not be sterilized to the appropriate level when reprocessed.
Cook Inc. is recalling 370 StoneBreaker Probe Caps because the interior may not be properly sterilized during reprocessing.
Cook Inc. is recalling 629 StoneBreaker Exhaust Caps because the interior may not be sterilized to the appropriate level when following reprocessing instructions.
Siemens is recalling 1,301 SOMATOM Sensation Open CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.
Siemens Medical Solutions is recalling 1,301 SOMATOM Emotion 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer systems because reporting and conversion factors may not apply to all connected analyzers.
Siemens is recalling SOMATOM Emotion Duo CT scanners because a software algorithm may calculate incorrect radiation doses for head scans, potentially exposing patients to unnecessary radiation.
Siemens is recalling 1,301 SOMATOM Sensation 16 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.
Siemens Medical Solutions is recalling SOMATOM Scope CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially leading to unnecessary radiation exposure.
Siemens is recalling 1,301 SOMATOM Sensation 40 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.
Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter because the device may not be properly sterilized during reprocessing.
Radiometer Medical ApS is recalling AQURE software versions 2.3.0 and 2.3.1 due to a potential problem that may result in patient mix-up.
Cook Inc. is recalling 12,556 StoneBreaker Single Use Probes because the interior may not be properly sterilized. The recall covers units distributed in the US and 70 other countries.
Zimmer Biomet is recalling 30 modular hip head components because two lots of different sizes were potentially commingled. This error could lead to the use of an incorrect sized head, causing surgery delays or dislocation.
Siemens is recalling 1,301 SOMATOM Sensation Cardiac CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.
Cook Inc. is recalling 470 StoneBreaker Sterilization Caps because the interior may not reach the required Sterility Assurance Level during reprocessing.
Siemens Medical Solutions is recalling 42 Biograph Horizon PET/CT scanners due to a software error that causes incorrect image reconstruction.
Roche Diagnostics is recalling cobas b 221 AutoQC Modules because a software defect prevents the scheduled quality control measurements from starting.
Beijing Syntech Laser is recalling six APOLLO JV+ Medical Platform surgical lasers because the required certification label was not affixed to the products.
Beijing Syntech Laser Co., Ltd is recalling 11 APOLLO V+ Medical Platform surgical lasers because the required certification label was not affixed to the product.
Roche Diagnostics is recalling 1,026 Omni S2 analyzers because a software defect prevents scheduled quality control measurements from starting.
Beaver-Visitec is recalling 110 Osher Thermodot Markers because they were manufactured with a needle tip instead of the proper flat tip.
Teleflex Medical is recalling 25 units of the LMA MADgic device due to missing or incomplete information on the package label.
Roche Diagnostics is recalling 1,026 OMNI S4 analyzers because a software defect prevents the AutoQC scheduler from activating.
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