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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.
Canon Medical System is recalling 35 Aquilion One CT scanners because a software error may interrupt scanning and prevent normal shutdown, causing loss of raw data.
Life Technologies is recalling 66 units of Oncomine Dx Target Test DNA Control-IVD because the expiration date was extended prior to clearance.
Canon Medical System is recalling 10 Aquilion Prime CT scanners because a software error may interrupt scanning and prevent normal shutdown, resulting in data loss.
Shanghai United Imaging Healthcare is recalling two uMI 550 PET/CT systems due to software bugs that may cause reconstruction problems and patient rescans.
Canon Medical System is recalling two Aquilion Premium CT scanners because a software error can interrupt scans and cause loss of raw data.
Boddingtons Plastics Ltd is recalling Endocuff Vision models ARV 110, 120, 130, and 140 to update instructions regarding contraindications and potential complications.
Canon Medical System is recalling two Aquilion One CT scanners because scanning errors may interrupt exams and force system reboots, resulting in the loss of acquired raw data.
Merit Medical Systems is recalling six units of nonsterile ChloraPrep applicators that were inadvertently shipped to a customer in Illinois.
Boston Scientific is voluntarily recalling 118 units of Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.
Canon Medical System is recalling one Aquilion Precision CT scanner because a software error may interrupt scanning and cause loss of raw data.
Canon Medical System is recalling one Aquilion One Vision CT scanner because a software error can interrupt scans and cause loss of raw data.
Boston Scientific is voluntarily correcting 40 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.
Life Technologies is recalling 35 units of the Oncomine Dx Target Test because the expiration date was extended prior to clearance.
Carolina Liquid Chemistries Corp is recalling SPICE (JWH-018) CC443 to correct labeling that clarifies the product is for research purposes only.
Life Technologies is recalling 79 units of the Ion Torrent Dx No Template Control Kit due to extended expiration dates prior to clearance.
Life Technologies is recalling 66 units of the Oncomine Dx Target Test RNA Control because the expiration date was extended prior to regulatory clearance.
Canon Medical System is recalling six Aquilion Lightning CT scanners because a software error can interrupt scanning and prevent normal shutdown, causing loss of raw data.
Boston Scientific is voluntarily recalling 110 Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.
CooperSurgical is recalling Wallace Artificial Insemination Catheters because the expiration date was marked as 5 years instead of 3 years.
Boston Scientific is voluntarily correcting 437 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.
Siemens is recalling specific ONCOR radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% overdose.
Zeiss is recalling a component for LSM 700, 800, and 900 microscopes because tilting the light arm can bypass laser safety, causing Class IIIB laser radiation emission.
Siemens Medical Solutions is recalling specific MEVATRON radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation overdose.
Siemens is recalling PRIMUS HI linear accelerators because a safety interlock defect could cause a 10-20% overdose of radiation therapy.
Siemens is recalling ARTISTE MV Systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation therapy overdose.
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