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.
Mindray DS USA, Inc. is recalling BeneVision Series Telemetry Monitor operator's manuals because descriptions of selected physiological alarm functions may be insufficient or require clarification.
Mindray DS USA, Inc. is recalling T1 Patient Monitor Operator's Manuals because descriptions of physiological alarm functions may be insufficient or require clarification.
Volcano Corp is recalling 19 Philips IntraSight Plus systems because software may incorrectly associate patient image data with the wrong medical record.
Medline is recalling specific homecare bed hand pendants because the pendant or wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire.
Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers due to a risk of blood-to-glycol leaks during cardiopulmonary bypass procedures.
Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers because a defect may cause blood to leak into the glycol heat transfer fluid.
Medline Industries is recalling Basic and Medlite Homecare Beds due to a potential fire hazard involving the hand control pendant and wiring.
Draeger is recalling VentStar Resus Neo neonatal breathing circuits due to potential hose cracks that could cause leakage or disconnection.
Penumbra Inc. is recalling 43 RED 62 Reperfusion Catheters due to manufacturing issues that may cause the catheters to fracture.
American Contract Systems Inc. is recalling 1,804 medical kits containing BD CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.
Philips is recalling Spectral CT 7500 software due to a tracking crash that may cause patients to receive additional radiation.
Heraeus Medical GmbH is recalling PALACOS R+G pro 40 and 80 bone cement due to a potential for monomer liquid leakage. The recall affects 59,660 units distributed worldwide.
American Contract Systems Inc. is recalling 1,804 medical convenience kits containing potentially contaminated perineal care wipes. The contamination may cause skin irritation or increase infection risk.
Percussionaire Corporation is recalling Travel Air and Phasitron 5 devices to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
Cardinal Health 200, LLC is recalling 344 Presource Packs containing Stryker tube sets because handpieces may leak fluid, creating a slip and fall hazard.
Heraeus Medical is recalling PALACOS R pro 40 and 80 bone cement because of a potential for monomer liquid leakage. The recall affects 33,727 units distributed worldwide.
American Nitrile Operations LLC is recalling 17,481,000 Opportunity Pro nitrile gloves nationwide due to defects like tears and debris that may expose users to pathogens or chemicals.
Cardinal Health is recalling 3,677 Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets because handpieces may leak fluid, creating a slip and fall hazard.
Heraeus Medical is recalling PALACOS MV pro 40 and 80 bone cement due to a potential for monomer liquid leakage. The recall covers all lot numbers distributed worldwide.
Shanghai United Imaging Healthcare is recalling four uCT 530 CT systems due to a software defect that may hide patient images, potentially requiring rescans.
Bard Peripheral Vascular Inc is recalling 99 EnCor EnCompass Breast Biopsy and Tissue Removal Systems due to software errors that may interrupt procedures.
Merit Medical Systems is recalling Embosphere microspheres because packaging holes may compromise sterility, posing an infection risk.
Alere San Diego is recalling hCG rapid test cassettes because they may detect low hormone levels, leading to false positive pregnancy results.
Percussionaire Corporation is recalling Impulsator and Phasitron 5 devices to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
Tandem Diabetes Care is recalling a beta version of its t:slim iOS app because it fails to pair with Abbott FreeStyle Libre 3 Plus sensors, forcing users into manual mode.
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