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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.
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.
Argon Medical Devices recalls PICC catheters that are mislabeled. Packages marked 26G/1.9Fr x 30cm actually contain 26G/1.9Fr x 50cm catheters, which could delay procedures.
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 have been recalled due to leaks, breakage, and quality issues that may harm patients. The recall affects over 1.6 million units distributed worldwide.
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 ambulatory infusion pumps (models 21-2120, 21-2125, 21-2127) worldwide. The FDA has classified this as a Class I recall.
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 Model 2110 infusion pumps in a Class I action affecting units worldwide.
GE Medical Systems is recalling 3.0T SIGNA HDxt MRI systems because radiofrequency energy can exceed safety limits under specific operating conditions, potentially overheating implanted medical devices in patients.
American Contract Systems is recalling Cataract Pack convenience kits due to insufficient aeration time during sterilization. The affected units may not be properly sterilized.
Artivion is recalling two CryoValve SG heart valve grafts that were approved and implanted with invalid test results.
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.
BD PYXIS automated medication dispensing cabinets contain a software issue that may print incorrect bin locations on restock labels. This could result in medications being placed in the wrong bin during restocking.
GE Medical Systems is recalling 404 SIGNA Premier MRI systems worldwide due to a software issue where radiofrequency energy can exceed prescribed safety limits during specific imaging sequences, potentially overheating MR-conditional implants.
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.
Philips IntelliVue Patient Monitor models with software L.x and M.x lack critical monitoring capabilities due to a software update. This could result in incorrect or delayed patient treatment.
A software issue in the BD PYXIS MEDBANK automated medication dispensing cabinet can cause incorrect bin labels to be printed for restock operations. This could lead to medication administration errors affecting patient safety.
CareFusion's BD PYXIS MEDBANK medication dispensing cabinets (software 3.9.1.9) have a software defect that may cause restock labels to print incorrect medication bin locations, creating a risk of medication dispensing errors.
Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.
Steris recalls Hookup Model 2-8-540CAS endoscope reprocessor units due to incorrect instructions that could prevent proper disinfection. Using incorrect hookup connections may lead to patient contamination or infection risk.
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 Medical Systems is recalling 72 SIGNA Prime MR imaging systems worldwide. Under specific imaging conditions, the systems can exceed prescribed radiofrequency safety limits, potentially causing MR conditional implants to overheat.
The FDA is recalling 180 Leica HistoCore Arcadia H paraffin embedding stations due to a sealing defect in the paraffin tank that can cause toxic smoke and internal fire.
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