Category
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.
Beckman Coulter is recalling 59 units of its Access 2 Immunoassay System Analyzer due to misaligned index wheels causing carousel motion errors that disable the analyzer and cancel patient tests.
Ortho-Clinical Diagnostics is recalling VITROS Folate Reagent Pack due to fibrinogen precipitation causing delayed test results. The recall affects 18,467 units distributed worldwide.
DRG International is recalling Salivary Testosterone ELISA kits (Model SLV-3013) due to out-of-range quality controls that invalidate test runs and delay patient results. The recall affects 257 units distributed nationwide in six states.
Medline is recalling over 1.6 million medical procedure kits nationwide and internationally due to plastic syringe defects. The affected kits contain syringes with leaks, breakage, and quality issues that may pose risks to patient health.
Covidien recalls 34,642 Puritan Bennett 500 Series Ventilators due to release of volatile organic compound (2-propanol, 1,3-dichloro) from gas pathway components during prolonged use beyond 10 years.
Medline procedure kits containing defective plastic syringes are being recalled nationwide. The syringes may leak, break, or have other quality issues that could pose a risk to patient health.
Smiths Medical is recalling CADD-Solis VIP ambulatory infusion pumps (models 21-2120, 21-2125, 21-2127) worldwide. The FDA has classified this as a Class I recall.
CADD-Solis Model 2100 infusion pumps with pre-v4.3 software have defects affecting occlusion detection and device responsiveness. Manufacturer recommends updating to software version 4.3 (2023) to resolve the issues.
Smiths Medical is recalling CADD-Solis VIP Model 2110 infusion pumps in a Class I action affecting units worldwide.
Medline procedure kits containing defective plastic syringes have been recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects over 1.6 million units distributed worldwide.
GE SIGNA Voyager MRI systems may exceed prescribed radiofrequency limits under specific operating conditions, risking overheating of MR conditional implants. The issue occurs with certain imaging sequences when the Optimized T2 FLAIR option is disabled.
Medline Industries is recalling Centurion procedure kits due to defective plastic syringes affected by an FDA safety alert. The syringes may leak or break and pose a potential risk to patient health.
A software defect in BD PYXIS MEDBANK automated medication dispensing cabinets may cause the incorrect medication bin to be printed on restock labels, potentially resulting in medication errors.
Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.
GE Medical Systems recalled 2,146 SIGNA 1.5T MR systems that may overheat implants during certain imaging sequences in Low SAR mode due to a software defect in radiofrequency safety calculations.
GE HealthCare is recalling certain MR750 MRI systems with specific software versions. When using particular imaging sequences in Low SAR Mode without the Optimized T2 FLAIR option, the radiofrequency field can exceed safe limits, risking overheating of MR-conditional implants.
A software error in GE SIGNA Hero MRI systems can cause overheating of MR conditional implants under specific conditions. The recall affects 95 units distributed worldwide.
GE HealthCare recalled certain SIGNA Creator MRI systems due to a software defect where the predicted magnetic field strength can exceed prescribed limits in Low SAR Mode with specific imaging sequences, potentially causing overheating of MR-conditional implants.
GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.
Philips IntelliVue Patient Monitors (models MX400/450/500/550) with software versions L.x or M.x are missing three monitoring capability options (MOS, M06, M20) due to software changes, creating potential for delayed or incorrect treatment. The recall involves 18 units distributed nationwide and internationally.
GE HealthCare recalled 23 SIGNA Victor MRI systems due to a software issue that can cause MR conditional implants to overheat. The defect occurs under specific imaging mode and configuration combinations.
GE HealthCare recalled SIGNA PET/MR systems with specific software versions due to a configuration issue that can cause RF energy to exceed safety limits, potentially overheating MR-conditional implants.
Medline has recalled Centurion procedure kits containing syringes affected by an FDA safety alert. The syringes may leak, break, or have other quality defects, posing a risk to patient health.
GE MR450w 1.5T MRI systems may overheat MR-conditional implants when using specific imaging sequences with Low SAR Mode. No injuries reported; 1,607 units affected worldwide.
A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.
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