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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.
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 9,720 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.
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.
Intuitive Surgical, Inc. is recalling the Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 due to a software error that can cause loss of user interface content on monitors.
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 808 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 240 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline Industries, LP is recalling certain Medline Convenience Kits (Dental Pack, Model DYNDA3003) because equipment calibration issues may have impacted the sterility of the products.
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Type S devices due to reports of adverse events.
Immunotech A.S. is recalling 160 Estrone RIA kits (REF: DSL8700) that may rarely give falsely high patient results, which could cause temporary injury with remote probability.
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Stryker is recalling the MOLLI 2 System due to magnetized surgical tools that may dislodge markers during target tissue removal procedures. The recall affects 5,864 units distributed worldwide.
Olympus Corporation of the Americas is recalling Olympus Thunderbeat 5 mm, 35 cm, Inline Grip devices due to reports of adverse events.
Medline is recalling 193,157 units of surgical packs 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, Inline Grip from the market, stating the action is due to continued reports of adverse events.
Medline Industries is recalling 154,427 medical device convenience kits due to calibration issues with sterilization equipment that could affect sterility assurance levels. No illnesses or injuries have been reported.
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 32 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
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.
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 Industries is recalling 779 units of convenience kits and setup trays due to potential sterility assurance issues from equipment calibration problems during manufacturing.
Medline Industries is recalling 4,853 medical device kits due to potential sterility issues from equipment calibration problems during manufacturing.
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Medline Industries, LP is recalling specific Medline Convenience Kits (CHEST/BREAST-LF) because equipment calibration issues may have impacted the sterility assurance level of the products.
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