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.
Bard Peripheral Vascular is recalling 14,935 Broviac 4.2 Fr single-lumen CV catheter cutdown trays because damage to the outer tray can potentially compromise the sterile barrier.
Medline is recalling 808 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Olympus is removing the Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip from the market, stating the action is due to continued reports of adverse events.
Medline is recalling 2,740 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 175 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 70,376,042 units of surgical gowns because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Centinel Spine is recalling 20 Prodisc C SK total cervical disc replacements because products were mislabeled as the 6mm product but included the 5mm product.
Medline is recalling 82,597 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 7,575 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Baxter Healthcare is recalling 5 Spectrum IQ Infusion Pumps because they were released without full testing being performed, including occlusion alarm testing.
Medline is recalling 72 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 684 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Olympus is removing the Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip from the market, stating the action is due to continued reports of adverse events.
Medline is recalling 32 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 108 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 59 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 7,725 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 553 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Integra LifeSciences is recalling 49,367 units of MediHoney Gel with Active Leptospermum Honey over potential packaging failures that could breach the sterile barrier.
Medica Corporation is recalling 1,578 capillary tube kits after a systematic positive bias of up to 20% was identified across the reportable potassium range.
Medline is recalling 30,958 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Olympus is removing the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S from the market, stating the action is due to continued reports of adverse events.
Medline is recalling 9,720 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Auris Health is recalling 173 MONARCH Platform bronchoscopy systems because a software restart can re-initialize the system to patient-left, leading to unanticipated robotic arm positioning.
Medline is recalling 14,927,765 units of surgical drapes because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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